RAC/M/27/2013
Final
14 February 2014
Minutes of the 27th Meeting
of the Committee for Risk Assessment (RAC-27)
2-5 December 2013
1
Part I Summary Record of the Proceedings
1.
Welcome and apologies
The Chairman, Tim Bowmer, welcomed all the participants to the 27th meeting of the
Committee for Risk Assessment (RAC). Apologies were received from three members. The
Chairman welcomed three new RAC members, and informed the Committee that one RAC
member had resigned. The participants were informed that the meeting would be recorded
solely for the purpose of writing the minutes and that this recording would be destroyed after
the adoption of the minutes. The Chairman noted that the minutes would be published on the
ECHA website and would include a full list of participants as given in Part III of these minutes.
2.
Adoption of the Agenda
The Chairman reviewed the week’s agenda.
One member raised the question of the confidentiality of the information contained in
applications for authorisation, and access to such documents.
The Final Draft Agenda (RAC/A/27/2013) was adopted without further modification. The
agenda and the list of all meeting documents are attached to these minutes as Annexes I and
II, respectively.
3.
Declarations of conflicts of interests to the Agenda
The Chairman informed the Committee in relation to the question raised by two RAC members
during the RAC 26 meeting who had questioned the practice of declaring a potential conflict of
interest when the dossier is submitted by a Member State Competent Authority or executing
agency by whom the member is employed and when this member has not been personally
involved in the preparation or evaluation of the dossier. In their view, excluding the member
from voting in case there is a potential conflict of interest declared on any dossier submitted
by the respective Competent Authority would not be in line with the request towards the
Competent Authorities to provide support to their nominated Committee members. The issue
was also brought to the attention of the Management Board by one of its members at its
September 2013 meeting. The Management Board referred the question to the ECHA Conflicts
of Interest Advisory Committee (CoIAC) who would consider the issue and advise the
Executive Director of ECHA accordingly. Pending the recommendation of the CoIAC, the
current practice will be maintained.
The Chairman then requested all participants to declare any potential conflicts of interest to
any of the agenda items. Fifteen members and two advisers declared potential conflicts of
interest, or had this declared for them by the Chairman, each to specific agenda items. In the
event of a vote, these meeting participants were requested to refrain from voting on the
respective agenda items, as stated in Article 9.2 of the RAC Rules of Procedure. The list of
persons declaring potential conflicts is attached to these minutes as Annex III.
The two RAC members that had raised the issue summarised above, repeated their objection
to the declaration, indicating that their written comments on one of the substances concerned
further illustrated their independence, as their opinion deviated from that of the dossier
submitter proposal. It was further argued that the current practice might lead to a nonexisting “conflict” of interest for many substances when a member is working at a large
Agency.
The Chairman reiterated that members with concurrent employment at a CA submitting a
dossier to the Committees were required to declare a potential conflict of interest in RAC and
SEAC on that specific case and that this applies to all members evenly. The RAC will be
informed of the outcome of the CoIAC discussion and the decision of ECHA if available at RAC
28 in March 2014.
4.
Report from other ECHA bodies and activities
a) Report on RAC-26 action points, written procedures and other ECHA bodies
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The Chairman informed the Committee that all action points of RAC-26 had been completed,
or were on-going. He also informed the Committee that the final minutes of RAC-26 had been
adopted via written procedure and were uploaded to CIRCABC and on the ECHA website on 22
November, and thanked those members who had provided comments on the draft. The
Chairman informed the Committee that the draft minutes from RAC-27 will be compiled and
sent for the RAC comments by 10 January 2014.
b) RAC work plan for all processes
The Chairman presented the updated RAC work-plan for 2014, covering the three processes of
restriction, authorisation and harmonised classification and labelling of substances. He
informed the meeting that the ongoing analysis of the workload for the Committees for 2014,
indicated a rise from 41 opinions in 2013 to ca. 71 in 2014 (40 CLH, 11 restrictions and 20 or
more authorisations) and noted that holding longer meetings (4.5 instead of 3.5 days) would
not be sufficient to meet this demand. Additional meetings would be needed.
The meeting dates listed on the RAC page of the ECHA website would be maintained he noted
and assuming some gains in efficiency, the extra 30 dossiers could be fitted into 6 regular
meetings (3.5 day; Tuesday 09:00 to Friday 13:30), instead of the usual 4.
Meetings ‘in between’ were considered to be problematic for the following reasons: the
timelines for restrictions and applications for authorisation are tied to very tight legal
deadlines, while the submission windows are synchronised to Committee dates. Already
moving at a fast pace, the quarterly meeting pattern suits the rhythm of CLH and gains the
maximum efficiency by allowing enough time for all parties, including rapporteurs to prepare
for each meeting and carry out the necessary follow-up afterwards.
ECHA therefore proposed to add the additional meetings immediately following the planned
March and December RAC meetings, making them in effect double meetings. In order to
provide some flexibility, the secretariat would ensure differentiation into partly separate
REACH (e.g. RAC 28A) and CLH (e.g. RAC 28B) agendas. A positive aspect of this would be
that the Authorisation process would be given more room to grow and mature, while the CLP
and Restriction processes would be able to gain further focus and efficiency.
The June and September meetings would remain unchanged, with normal mixed agendas for
all processes. The Chairman concluded that the amended schedule for the March meetings
would be announced before the end of the year.
5.
Harmonised classification and labelling (CLH)
5.1 CLH dossiers
a) Sulfoxaflor
The Chairman welcomed an expert accompanying the ECPA stakeholder observer. He reported
that sulfoxaflor was a new insecticide with a novel functional group acting as an agonist to the
nicotinic acetylcholine receptors of insects. The CLH dossier was submitted by Ireland and in
parallel, the active substance was under peer review by EFSA. The legal deadline for adoption
of the CLH opinion is 6 August 2014.
Sulfoxaflor currently has no harmonised classification in Annex VI to the CLP Regulation. The
dossier submitter had proposed to classify the substance as Acute Tox. 4 (H302), Aquatic
Acute 1 (H400) and Aquatic Chronic 1 (H410), with an M-factor of 1 for both aquatic hazard
classes.
The Chairman noted that at RAC-26, the Committee had already agreed on harmonised
classifications as Acute Tox. 4 (H302) and as Aquatic Acute 1 (H400) and Chronic 1 (H410),
with an M-factor of 1 in both cases. At RAC-27 carcinogenicity and reproductive toxicity were
the only endpoints left over for discussion. For both endpoints, several toxicity studies and a
series of mechanistic studies needed to be evaluated, including a late mechanistic study on
reproductive toxicity that was provided by the applicant under the EFSA process and which
had previously been announced during the ECHA Public Consultation.
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Where carcinogenicity was concerned, the Committee discussed the liver cell tumours
observed in male and female mice and male rats and the mechanistic studies on the
constitutive androstane receptor (CAR)(/pregnane X receptor (PXR)) mediated mode of action
(MoA). The DS considered this MoA not relevant for humans. The absence of hepatocellular
proliferation in a mechanistic study using humanised and knock-out CAR/PXR mice, was
considered further evidence for the non-relevance to humans. The Committee questioned the
use of the humanised mice model as only one gene has been changed in these mice and the
model would not necessarily represent the full mechanism in humans. It was also noted that
although liver tumours were likely formed via the CAR(/PXR) mediated mechanism, with key
events in this MoA shown in male and female rats and mice, there were also some different
responses between these species and between the sexes. It was pointed out that humans may
be less sensitive to liver tumour formation via this MoA, but that this does not necessarily
mean the absence of hazard to humans.
As RAC did not have any detailed data on phenobarbital, it was considered difficult to use this
as a reference substance for the above mode of action. As a result, it was proposed not to
refer to phenobarbital in the discussions.
It was noted that in the experiment with humanised mice there was a lack of positive controls
showing that increased liver cell proliferation led to liver tumours in the same animals. A
delayed proliferation was also considered as possible in humanised CAR/PXR mice, but this
could not be concluded as the length of the experiment was only seven days. Some members
commented that the CAR mediated mechanism in liver tumour formation is not relevant for
humans. The key question was therefore whether other mechanisms could be excluded.
According to the Rapporteur the mode of action was not genotoxic and other mode of actions
were shown to be unlikely. Although the increased liver tumour incidences may have
warranted classification for carcinogenicity, the Committee in the end concluded on no
classification based on the totality of mechanistic evidence presented for sulfoxaflor. RAC
considered a CAR-mediated, mitogenic MoA behind the liver tumours most likely for
sulfoxaflor, but as humans do not seem to undergo the sulfoxaflor-induced proliferative
response (as shown in humanised mice), liver tumours are not expected to occur in humans.
RAC pointed out that this case was unique and should not be seen as a precedent for similar
cases in the future: when a CAR-mediated MoA is claimed for a substance, sufficient and good
quality data will have to be provided showing the presence or absence of key events
supporting the MoA and the (non-)relevance to humans. While industry noted that the case
against human relevance of the CAR-mediated MoA was strong enough even without the
knock-out and humanised mice studies, the RAC felt that the evidence could have been
stronger and further confirmatory studies would be desirable in future.
The overall evidence of Leydig cell tumours and preputial gland tumours observed only in male
rats appeared too weak to justify classification. Therefore, the RAC agreed that classification
for carcinogenicity was not warranted.
With regard to reproductive toxicity, the RAC agreed not to classify sulfoxaflor for this hazard
class, despite the substance inducing some very specific foetal abnormalities together with
reduced postnatal survival. RAC concluded that the mechanistic studies into the MoA behind
these effects presented sufficient evidence for the non-relevance to humans.
The RAC adopted the opinion on sulfoxaflor by consensus. The Chairman thanked the
Rapporteur(s) for their clear presentation of the arguments and the Committee for their
participation in the discussions.
b) Phenol, dodecyl-, branched (TPP)
The Chairman welcomed representatives of the two industry dossier submitters. He reported
that phenol, dodecyl, branched was a UVCB substance, i.e. a complex mixture of branched
alkyl-substituted phenols which is widely used by the chemical industry for the synthesis of
polymers from monomers.
He noted that TPP currently had no harmonised classification in Annex VI to the CLP
Regulation and that a harmonised classification would apply to any substance which
predominantly contained C12 (branched) alkyl-substituted phenols.
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One dossier submitter had proposed to classify the substance for Skin Irrit. 2 (H315), Eye Irrit.
2 (H319), Repr. 2 (H361f), and for Aquatic Acute 1 (H400) with an M-factor of 1, and Aquatic
Chronic 1 (H410) with an M-factor of 10. On the basis of the information contained in their
dossier, the Committee had already agreed at RAC-26 to classify the substance as Skin Corr.
1C, and as Aquatic Acute 1 and Chronic 1, with an M-factor of 10 for both aquatic hazard
classes.
The Chairman informed the Committee that the two dossiers were being tabled for a second
discussion in the RAC, in order to discuss toxicity to reproduction which was also proposed by
the second industry dossier submitter, but with a different classification than the first one,
namely as Repr. 1B (H360F) with a specific concentration limit (SCL) of 1.5 %.
The Chairman clarified that the information contained in both dossiers as well as the
comments received under PC would have to be discussed together in order to decide on
reproductive toxicity.
The Rapporteur presented the data on reproductive toxicity, as well as the argumentation from
the two dossier submitters for the classification proposals, Repr. 2 versus 1B (the latter with a
SCL of 1.5 %).
During the discussion, several RAC members expressed support for Repr. 1B, considering the
existing database presented in the CLH dossiers, including several reproductive toxicity studies
as well as supporting studies. It was stated that the effects seen, on e.g. female reproduction,
could not be explained by the reduced body weight gain compared to concurrent controls, and
it was noted that adverse effects on reproduction were also seen where there were no effects
on body weight. Following a question from one RAC member, it was further clarified that in the
studies on TPP, there was a reduction in body weight gain and final body weight compared to
controls, but not an actual body weight loss. Hence, it was concluded that the feed restriction
studies could not support the argumentation of one dossier submitter that the reproductive
effects could be a non-specific secondary effect caused by the effects on body weight.
The Rapporteur further presented calculations on the concentration limit, and concluded that
the proposed SCL of 1.5 % was not appropriate. According to the calculations, made according
to the Guidance on the application of CLP criteria, TPP is of medium potency, and hence the
general concentration limit would apply.
It was agreed to classify TPP into Repr. 1B (H360F) without assigning a SCL. It was further
agreed not to classify TPP for developmental toxicity and for effects on or via lactation. The
Committee adopted the opinion on phenol, dodecyl, branched by consensus. The Chairman
thanked the Rapporteur(s) for their presentation of the arguments and the Committee for their
participation in the discussions.
c) Lead
The Chairman welcomed an expert accompanying the Eurometaux stakeholder observer. He
reported that lead had a variety of uses, both for industrial purposes as well as in consumer
products.
Metallic lead currently has no harmonised classification in Annex VI to the CLP Regulation. The
dossier submitter (Sweden) proposed to classify the substance, including all physical forms of
lead, as Repr. 1A (H360FD), with a specific concentration limit of 0.03%.
While the RAC had already agreed at RAC-26 to classify lead (all forms) as Repr. 1A for both
development and fertility (H360DF) as well as for effects on or via lactation (Lact., H362), the
discussion on specific concentration limits and the overall scope of the lead entry in Annex VI
still needed to be finalised.
The Chairman invited the Rapporteur to present the options related to both questions.
The Rapporteur proposed a SCL of 0.03% for development based on a drop of 1-5 IQ points at
a blood lead level of 100 µg/l, both maternally and post-natally. This blood lead level is
achieved at external doses from 330 µg/kg/day. No SCL was proposed by the Rapporteur for
fertility effects. The Rapporteur also noted the option of having two entries for lead, one for
lead powder with the proposed SCL and one for the massive form without SCL. During the
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subsequent discussions, the Committee recognised that lead was a highly potent substance
which needed to be reflected by a specific concentration limit. The RAC was of the opinion that
on the basis of the bioavailability data presented for particulate lead, estimates of doses for
massive forms were unclear. Additionally, small particles would be expected to form during
reasonable handling and use of massive lead. Splitting the entry for lead with regard to the
assignment of SCL’s was therefore not considered justified and the RAC agreed on a SCL of
0.03% for developmental effects.
The Committee adopted the opinion on lead by consensus. The Chairman thanked the
Rapporteur(s) for their presentation of the arguments and the Committee for their
participation in the discussions.
d) Anti-coagulant rodenticides
The Chairman welcomed an expert accompanying the ECPA stakeholder observer and reported
that the eight dossiers submitted by eight different dossier submitters (Ireland, Italy, the
Netherlands, Sweden, Norway, Denmark, Spain, Finland) would be considered in detailed
substance-by-substance analyses, taking all available data into account including data on
warfarin, in a weight of evidence assessment (in accordance with the CLP criteria) as agreed
upon at RAC 26 when the general discussion on AVKs had taken place. The substances belong
to a group of anticoagulant rodenticides, i.e. those with an anti-vitamin K mode of action
(AVKs) and are used mainly as the active substances in biocidal products for pest control of
rats, mice and other rodents.
Some substances already have a harmonised classification in Annex VI to the CLP Regulation,
however only Warfarin is classified for toxicity to reproduction as Repr. 1A (H360D).The
discussion on developmental toxicity of the 7 other AVKs were never finalised by the TC C&L
and were handed-over to ECHA.
Toxicity to reproduction of the first two dossiers (Brodifacoum and Flocoumafen) for which first
draft opinions were prepared was discussed together and the following issues were
considered: mode of action (MoA), animal data, human data, placental transfer and
toxicokinetics.
One RAC member stressed that a common understanding of the interpretation of human data
on Warfarin and other AVK substances/agents and the animal data on Warfarin would be
needed for further discussion on individual dossiers, which was supported by other RAC
members. Also, the predictability of the standard developmental toxicity study (OECD TG 414)
of the effects seen in humans (including the typical warfarin embryopathy syndrome) would
need to be clarified in order to provide adequate weight to the animal data in the weight of
evidence analysis. In addition, it was noted that both maternal toxicity and developmental
effects in the animal studies have to be evaluated in detail if a comparison should be made
between Warfarin and the other AVKs with regard to available animal data.
The RAC agreed that both substances, as well as Warfarin, act with an identical mode of
action. However, for some members a common / identical MoA on its own was not seen as
sufficient for classification and they stated that a broader assessment would be needed before
a final conclusion could be made.
Although one RAC member was of the opinion that developmental toxicity is clearly shown in
the rat warfarin studies, several RAC members commented that the results from these studies,
in particular the study by Kubaszky (2009), were weak and/or equivocal (e.g. because of low
incidences, lack of dose response and severe/unclear maternal toxicity). Two RAC members
reminded the Committee that the typical human nasal skeletal malformations have only been
demonstrated in the rat after post-natal exposure with concurrent supplement of vitamin K
(Howe and Webster, 1992). This statement was challenged by the expert from ECPA who
noted that the post-natal nasal elongation measured in Howe and Webster represented a
different growth process than the cellular and tissue reorganisation and migration that occurs
during the critical window of teratogenesis. The Chairman summarised that several RAC
members considered that the animal data on warfarin had weaknesses and that no firm
conclusion could be drawn. However, the warfarin data could be considered again in the
context of each AVK case.
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Concerning the human data on Warfarin, several RAC members underlined that the effects
seen in the foetuses were irreversible and severe (malformations and death) in contrast to the
maternal therapeutic effects (including prolongation of blood coagulation time).
The RAC agreed that in case of a direct effect on the embryo/foetus, both substances have a
potential to cross the placenta in the rat although the extent of the transfer may differ.
Flocoumafen has a higher binding affinity to the maternal liver than warfarin but also a much
longer half time in the maternal liver.
1. Brodifacoum
Brodifacoum already has a harmonised classification in Annex VI to the CLP, the current entry
being Acute Tox. 1; H310, Acute Tox. 2*; H300, STOT RE 1; H372**, and environmental
hazards Aquatic Acute 1; H400 and Aquatic Chronic 1; H410.
As to reproduction, the Rapporteur supported the DS proposal (which originally was to add
Repr. 1B for developmental toxicity but was revised to addition of Repr. 1A after the public
consultation (PC)). There were 5 experimental animal studies (rats and rabbits), all of them
“negative”, one case report on an accidental exposure of a dog with foetotoxic findings (7 out
of 13 pups died of haemorrhage at birth or within 2 days after birth) and in addition 3 clinical
cases of exposure of pregnant women with Brodifacoum, of which two showed evidence of
developmental toxicity. According to the Rapporteur, the proposal was justified by a) an
identical MoA as for Warfarin and other therapeutic coumarins which are teratogenic in the
human, b) by the two human cases where the offspring were more severely affected than the
mothers even if they were treated with vitamin K, c) by the dog case study and finally, d) by
uncertainties in relation to the reliability of the experimental animal data in predicting effects
in humans.
Considering the 3 clinical reports with regard to brodifacoum exposure, the expert from ECPA
pointed out that the level of toxicity to the mothers was sufficiently high and that all women
were treated with vitamin K to prevent anticoagulation. He noted that effects on human
foetuses were observed in the presence of severe maternal toxicity. In his view, the quality of
the clinical reports did not meet the criteria for Cat 1 A. Further, the expert from ECPA noted
that according to his interpretation of the criteria (i.e. Table 3.7.1(a) of Annex 1 to the
Regulation), such ‘uncertainty’ could only be used for “downgrading” the classification (and not
the other way round).In the discussion, several RAC members commented that the human and
dog data on Brodifacoum seemed to fit with the developmental toxicity profile related to
Warfarin and other human medicinal drugs with the same MoA/mechanism of action. Other
members questioned whether these cases were well enough reported to provide the necessary
weight of evidence. The RAC finally agreed on the proposed classification for developmental
toxicity (Repr. 1A; H360D) based on the set of evidence as summarised by the Rapporteur.
Other proposed hazard classes (modification of Acute toxicity and Skin sensitisation) will be
discussed at the next meeting.
2. Flocoumafen
Flocoumafen already has a harmonised classification in Annex VI to the CLP, the current entry
being Acute Tox. 2*; H330, Acute Tox. 1; H310, Acute Tox. 2*; H300, STOT RE 1; H372**,
and environmental hazards Aquatic Acute 1; H400 and Aquatic Chronic 1; H410.
The Rapporteur supported the DS proposal for modifications of the minimum classification for
Acute toxicity for oral, and inhalation routes (Acute Tox. 1; H300, Acute Tox. 1; H330) based
on the results of the studies in rats (oral), resp. rats and mice (inhalation). The RAC agreed on
the proposed modifications.
The Rapporteur supported the DS proposal for modification of the hazard statement for
classification for specific target organ toxicity after repeated exposure (STOT RE 1) i.e. to
delete the “**” for H372 in the current Annex entry, in order to indicate that all routes are of
concern, based on the outcome of a 90-day study in rats. The RAC agreed to this modification
of the hazard statement of H372.
The developmental toxicity of Flocoumafen and the DS’s proposal to add a Repr. 2
classification for this endpoint were not discussed in detail due to time constraints and will be
resumed at the next meeting. The Committee also agreed - due to time constraints – to deal
with environmental classification for all eight anticoagulant rodenticides via written procedure.
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The Chairman thanked the Rapporteurs for their presentation of the arguments and the
Committee for their participation in the discussion.
e) Triflusulfuron methyl
The Chairman welcomed an expert accompanying the ECPA stakeholder observer The
Chairman reported that the substance is an herbicide to be used in agriculture under field
conditions and the dossier was submitted by France. In the EU Plant Protection Products (PPP)
dossier, representative uses are for sugar and fodder beets. The substance has no harmonised
classification in the Annex VI to the CLP Regulation. The dossier submitter proposed to classify
triflusulfuron methyl as Carc. 2 (H351), Aquatic Acute 1 (H400, M-factor 100), and Aquatic
Chronic 1 (H410, M-factor 10). During the public consultation, comments from seven Member
State Competent Authorities were received and were addressed in the second draft opinion.
The Chairman stated that all hazard classes proposed in the dossier would be discussed in the
meeting and invited the Rapporteurs to present the draft opinion and the comments received
during the public consultation.
In the Rapporteurs’ presentation, covering all physico-chemical and human health endpoints, it
was concluded that the proposal by the dossier submitter to classify the substance as Carc. 2
(H351) was justified. Increase in incidences of interstitial cells hyperplasia (Leydig cells,
testes) and adenomas were seen at the two highest dose levels in male rats and a slight
increase in hepatocellular adenomas were seen in male mice. The Rapporteur also noted that
late in the process (the week before the RAC plenary) industry had submitted additional data,
challenging the proposal on carcinogenicity by the dossier submitter and the RAC Rapporteur.
The Chairman noted that the aforementioned information had only been provided to ECHA
shortly before the meeting and further pointed out that the appropriate time to provide such
information was during the public consultation. While it had been passed on to the
Rapporteurs and the RAC, it was too short notice to assess its significance and consider it
properly. After brief discussion RAC decided not to delay the process, and to base its decision
on the data already available.
RAC also agreed with the recommendation of the Rapporteurs to classify the substance for the
environmental toxicity endpoints. In accordance with the dossier submitter’s proposal, the
classification should be Aquatic Acute 1 (H400, M-factor 100) and Aquatic Chronic 1 (H410, Mfactor 10), confirmed despite minor corrections, i.e. recalculation of initial measured
concentrations and preference of 7d values, the other duckweed test then turning out as the
key study for chronic classification.
The Committee adopted the opinion on triflusulfuron methyl by consensus. The Chairman
thanked the Rapporteurs for their presentation of the arguments and the Committee for their
participation in the discussion.
f) Bifenazate
The Chairman welcomed an expert accompanying the ECPA stakeholder observer. He reported
that bifenazate is a new active substance, for use as an acaricide in crops and ornamentals
and that it has no Annex VI entry. The CLH dossier was submitted by the Netherlands.
The dossier submitter had proposed to classify the substance for Skin sensitisation 1B; H317,
for STOT RE 2; H373, for Aquatic Acute 1; H400 with an M-factor of 1 and for Aquatic Chronic
1; H410 with an M-factor of 1.
Based on a negative Buehler test and a positive guinea pig maximisation test (GPMT) the DS
proposed to classify bifenazate as Skin Sens 1B. With specific reference to the results in the
GPMT (which does not preclude classification for 1A since a sensitisation rate of >60% at 1%
concentration cannot be excluded) the RAC decided to classify the substance without a subcategorisation, i.e. as Skin Sens. 1.
Concerning repeated dose toxicity, the Rapporteurs proposed to classify bifenazate as STOT RE
2, based on mortality observed in the 28-d oral studies in mouse and rat, supported by
haematotoxicity. In longer-term studies, the haematology effects were confirmed in the dog
only. No specific target organ was proposed for the CLP classification because the blood
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system could not be unequivocally identified as the target organ responsible for mortality. The
criteria for classification were fulfilled under CLP but not under DSD and this conclusion was
supported by the RAC.
Although the DS had not proposed classification for the following hazard classes, the
Rapporteur presented the data concerning: mutagenicity, carcinogenicity and reproductive
toxicity. After a careful and detailed analysis of this data, RAC agreed with the DS and the
Rapporteur’s conclusion to not classify the substance for these endpoints.
The co-Rapporteur agreed with the original proposal of the dossier submitter to classify
bifenazate according to the CLP criteria as Aquatic Acute 1 (H400) with an M-factor acute of 1
and Aquatic Chronic 1 (H410) with an M-factor chronic of 1. The RAC agreed with the
proposed classification.
In summary, the RAC agreed to classify the substance as STOT RE 2; H373, Skin Sens. 1;
H317 (without subcategory), Aquatic Acute 1; H400, M=1, Aquatic Chronic 1; H410, M=1.
The opinion on bifenazate was adopted by consensus. The Chairman thanked the Rapporteurs
for their presentation of the arguments and the Committee for their participation in the
discussions.
g) Fenpyroximate
The Chairman reported that fenpyroximate was an active substance used as a PPP. Therefore,
RAC needed to evaluate all hazard classes for which the dossier submitter (Germany) has
provided appropriate information.
Fenpyroximate currently has no harmonised classification in Annex VI to the CLP Regulation.
The dossier submitter proposed to classify the substance as Acute Tox. 3; H301, Acute Tox. 2;
H330, Skin Sens. 1B; H317, Eye Irrit. 2; H319, Aquatic Acute 1; H400, M=100, Aquatic
Chronic 1; H410, M=1000. The originally proposed classification for Eye Irritation 2 was
withdrawn by the dossier submitter after the public consultation.
The Rapporteurs guided the Committee through all hazard classes for which the dossier
submitter provided information. Concerning eye irritation, the Rapporteur noted that the
available human data from humans was insufficient for classification and the most relevant
primary eye irritation study with the active substance fenpyroximate in rabbits was negative.
The RAC therefore agreed that classification for eye irritation was not appropriate.
The RAC asked the Rapporteur to make additions to the STOT RE section of the opinion, i.e. to
include information on whether there were findings in the organs of those dogs that were not
sacrificed before the end of the study and in addition, a minor clarification to the reproductive
toxicity section. However, classification was not considered appropriate for either of these
endpoints.
The RAC agreed to classify the substance as proposed by the DS.
RAC adopted the opinion on fenpyroximate by consensus. The Chairman thanked the
Rapporteur(s) for their presentation of the arguments and the Committee for their
participation in the discussions.
h) Lenacil
The Chairman reported that the substance is an herbicide used in agriculture and that it has
no harmonised classification. The CLH dossier was submitted by Belgium.
The dossier submitter proposed to classify the substance as Aquatic Acute 1 (H400) and
Aquatic Chronic 1 (H410) with M factors of 10. No classification was proposed for human
health hazards.
The Rapporteur presented all hazard classes related to human health and carcinogenicity was
discussed in detail. The RAC analysed the data related to increased incidences of thyroid
(follicular and c-cells) and mammary gland tumours in female rats and of lung and liver
tumours in male mice. There was no mechanism of action presented. Single and combined
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incidences of tumours (adenomas, adenocarcinomas and carcinomas) occurring in rats and
mice were compared with historical control data (HCD). At the request of the Chairman, the
industry expert (ECPA) provided additional information on the origin of the ‘updated’ set of
HCD. RAC members also asked for additional information on the mean values of the HDC data
because only ranges had been presented. The Rapporteur then provided additional details to
RAC regarding some of the mean values. Based on that, RAC concluded that for one tumour
type, i.e. those in mammary gland of female rats, the incidences were higher than could be
expected from the HCD. RAC therefore agreed to classify lenacil as carcinogen Cat 2.
For the environment, it was concluded that lenacil is not readily/rapidly degradable, has a low
potential to bioaccumulate and that there are adequate acute and chronic toxicity data
available on fish, daphnia, algae and aquatic plant Lemna. The RAC agreed to the proposal by
Belgium to classify lenacil as very toxic to aquatic life with long lasting effects (Aquatic Acute 1
and Aquatic Chronic 1, M=10 in both cases).
RAC adopted the opinion on lenacil by consensus. The Chairman thanked the Rapporteurs for
their presentation of the arguments and the Committee for their participation in the
discussions.
i) Tributyltin Compounds
The Chairman reported that tributyltin chloride and tributyltin oxide are used as an
intermediate for production of other organotin compounds. The current entry in Annex VI of
the CLP Regulation covers ‘tributyltin compounds with the exception of those specified
elsewhere in this Annex’ and comprises (along with relevant SCLs and M factors) Acute toxicity
(minimum classifications for oral and dermal route), STOT RE 1; H372**, Eye Irrit. 2; H319
and Skin Irrit. 2; H315 and environmental hazards Aquatic Acute 1; H400 and Aquatic Chronic
1; H410.
The DS (Germany) proposed to classify the substance as Repr. 1B; H360Fd and to modify the
existing minimum classifications for acute toxicity to Acute Tox. 3; H301 and Acute Tox. 3;
H311.
The RAC agreed with the DS to modify the classification for acute toxicity via the oral route,
but considered the data for modifying the classification for acute toxicity via the dermal route
insufficient and therefore agreed to leave the current minimum classification unchanged.
The RAC agreed with the proposal of the DS to classify the substance for toxicity to
reproduction – fertility as Repr 1B, based on the evidence for adverse effects on fertility in
males and females in animal studies.
The discussion then focused on developmental toxicity for which the DS proposed classification
as Repr. 2 (H360Fd). Several effects were observed, and whereas most findings were
considered by the DS to be secondary non-specific effects related to maternal toxicity (mainly
decreased maternal body weight), this was not so clear for the malformations (including cleft
palate) observed in two species (rats and mice), hence the proposal for Repr. 2. During the
discussion it was noted that a dose-response relationship in the increase in cleft palates was
observed in several studies and that cleft palate was a rare malformation and this warranted
classification as Repr. 1B for developmental toxicity. The RAC agreed to classify the substance
for developmental toxicity as Repr. 1B. The opinion on tributyltin compounds was adopted by
consensus.
The Chairman thanked the Rapporteur for his presentation of the arguments and the
Committee for their participation in the discussion and pointed out that final revision to reflect
the discussion at RAC 27 and an editorial check would be performed before the opinion would
be published on the ECHA website.
5.2 Appointment of RAC (Co-) Rapporteurs for CLH dossiers
The Secretariat collected the names of volunteers for the CLH dossiers listed in the room
document and the Committee agreed upon the proposed appointments of the (Co-)
Rapporteurs for the intentions and/or newly submitted CLH dossiers.
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5.3 General and procedural CLH issues
a) New template for a CLH report
At the request of one RAC member, the Secretariat updated the Committee about the status of
the new CLH report template which had been sent to CARACAL for information for their
November meeting.
One member argued that should the new template be implemented in its current form, for
every CLH dossier, its use (production and subsequent assessment) would have significant
time and resource-related implications for the CAs, RAC and ECHA. This increased burden
would not according to the RAC member outweigh the benefits the ECHA hoped would be
gained by requesting additional information for all dossiers and all endpoints (Section 13.
Detailed Study Summaries of the template).
In addition, in his view, this additional information would not facilitate really complicated
cases, as for such dossiers the experience of the committee has shown how scrutiny of the
original study reports is often preferred. This RAC member requested that ECHA reconsider
their proposal, noting that the implications of the changes had not been explained in full to
Member State Competent Authorities. As a possible compromise, the suggested application of
the new Section 13 could be made optional. This position was supported by three other RAC
members, in particular with reference to transferring information from Biocides CAR
documents.
In response to these comments the Secretariat explained the background to the preparation of
the new template which was mainly driven by the need to increase the efficiency of the CLH
process, and on recent experience with the opinion development process. The Secretariat
noted the members’ comments and reiterated an earlier offer of assistance to the CAs in the
preparation of CLH proposals.
In a final comment, the RAC member explained that his motivation was to ensure that the CLH
working process remained efficient and productive, as well as robust.
6.
Restriction
6.1 General restriction issues
a) Update on intended restriction dossiers
The Committee was provided with an update on intended restriction dossiers and informed
that the Registry of Intentions currently includes the following notifications:
-
Ammonium salts in cellulose wadding insulation materials used in buildings. ECHA has
received a registration of intent for the submission of an Annex XV restriction proposal.
In August 2013, France informed the Commission, ECHA and the other MSs, in
accordance with Article 129(1) of the REACH Regulation (safeguard clause), it had
justifiable grounds for believing that urgent action was essential to protect the public
from exposure to ammonia released from ammonium salts in such building materials.
France adopted a provisional measure in June and in September 2013, the Commission
authorised this provisional measure. Article 129(1) of REACH states that if the
provisional measure taken by the MS consists in a restriction on the placing on the
market or use of a substance, the MS concerned shall initiate a Union restriction
procedure by submitting to ECHA a dossier, in accordance with Annex XV, within 3
months of the date of the Commission decision. The expected submission date is 15
January 2014.
-
Chrysotile in diaphragms for the use in the chloralkali industry (to be submitted by
ECHA on request of the Commission in January 2014);
-
Cadmium and its compounds in plastics (to be submitted by ECHA on request of the
Commission in January 2014 - however, ECHA has not been able to get information
based on which it could be able to finalise an Annex XV restriction report by 17 January
2014);
11
-
Cadmium and its compounds in artist paints (to be submitted by Sweden in January
2014);
-
Bisphenol A in thermal paper (to be submitted by France in January 2014);
-
Bis(pentabromophenyl) ether (DecaBDE) (to be submitted by ECHA on request of
the Commission in August 2014).
b) Revision of the restriction process
The ECHA secretariat informed RAC that concerns have been raised about the workload
relating to the preparation of restriction proposals and the efficiency of the opinion making
process. In addition, the Commission services and ECHA secretariat have discussed to what
extent the output of the restriction process, i.e. opinions provided by the two scientific
committees of ECHA, satisfies the needs of the Commission for its decision making. In
response to these discussions, the Commission and ECHA propose to first carry out a survey to
better identify some of the problems. The Committee was informed that during December
2013, a questionnaire would be sent to the members, MSCAs and accredited stakeholder
observers of RAC and SEAC. It was also proposed to establish a task force to discuss the
issues raised in the questionnaire, to analyse the results, identify the core issues and suggest
solutions by spring 2014. The RAC members interested in taking part in the work of this task
force were encouraged to express their interest to ECHA by 21 December 2013.
In relation to the discussion on the streamlining of the REACH restriction process and in light
of the growing workload of RAC and SEAC, the Secretariat proposed to review and simplify the
current Committees' working procedures for processing of restriction dossiers. Several RAC
members welcomed the initiative of the Secretariat.
The Committee agreed to the revised working procedure on the conformity check of Annex XV
restriction dossiers as proposed by the Secretariat with one additional modification (the initial
commenting round to last until Day 12), as part of the above review.
RAC was then informed that the Secretariat would also revise the working procedure for
developing opinions on restriction dossiers and schedule it for discussion and agreement at the
next plenary meeting.
6.2 Restriction Annex XV dossiers
a) Lead in consumer articles – fourth version of the draft opinion
The Chairman welcomed the dossier submitter’s representative (SE), as well as the SEAC (co-)
Rapporteur, who both followed the discussion remotely via WebEx.
He then introduced the state of play with the development of the opinion for the proposed
restriction, on the placing on the market of lead and its compounds in articles intended for
consumer use and that the opinion should be adopted at this meeting based on the modified
fourth version (i.e. amendments made based on two written commenting rounds in October
and November) of the RAC draft opinion. The Chairman restated that the proposal is targeted
at consumer articles that could be placed in the mouth by children, considering that children
are the most vulnerable population group when exposed to lead. Lead has been shown to be a
non-threshold substance for neurotoxic and neurodevelopmental effects. The main route
through which small children (between ages of 6 and 36 months) are exposed to lead from
consumer articles is by mouthing. The key negative effect from such exposure is the
impairment of the development of the Central Nervous System.
The RAC Rapporteurs presented the modified fourth version of the draft RAC opinion, with a
focus on the minor modifications on the wording of the scope, and clarification of terms such
as the ‘tip’ of pens, as well as specific changes made to the opinion (e.g. referring to the
expression of mouthing times and the justification for the proposed exemptions based on risk).
The RAC discussed how to deal with outdoor articles; it was pointed out that in southern parts
of Europe, the likelihood of exposure from mouthing outdoor articles would be higher due to
12
the fact that children spend a longer time outdoors, e.g. in the garden in warmer climates.
After a short exchange of views, RAC concluded that outdoor articles would be left in the scope
(as already agreed at RAC-26). However as a result, one member considered that there was
insufficient information in the dossier to conclude that there would be a risk with respect to all
outdoor articles.
In addition, RAC discussed how to deal with musical instruments, keys, locks and padlocks
which were originally proposed by the dossier submitter to be exempted from the proposed
restriction. The Secretariat explained that in order to avoid challenges on procedural grounds,
even if they posed a risk, they could not now be included in the restriction, as they were not
considered during the public consultation on the original Annex XV dossier.
The Secretariat agreed to prepare a note on how to deal with scope/derogation issues during
opinion making (including public consultation) in the future.
In conclusion, the RAC agreed to the proposed restriction by a simple majority. Four members
reserved their position pending the final wording of the text. The Secretariat was requested to
launch a written procedure to adopt the modified text of the opinion, which would close by 10
December 2013.
The Chairman thanked the Rapporteurs and all those who had contributed to an intense and
fruitful debate in preceding weeks.
b) Nonylphenol – 1st version of the draft opinion
The Chairman welcomed the dossier submitter representatives (SE) who followed the
discussion remotely via WebEx.
The RAC Rapporteurs explained in relation to the environmental hazards that the application of
Assessment Factors (AF) and Species Sensitivity Distribution (SSD) approaches to standard
end point data led to very similar Predicted No Effect Concentrations (PNEC), consistent with
those from the REACH Chemical Safety Reports (CSR). The dossier derived a marine PNEC
separately from the freshwater PNEC, but the RAC Rapporteurs thought that this created an
artificial distinction in the levels of toxicity and therefore recommend merging marine and
freshwater data. Several RAC members supported the Rapporteurs' suggestion to have a
combined PNEC with the value of 0.39 µg/L.
In relation to the Endocrine Disrupting (ED) effects of NP, the Rapporteurs noted that the
dossier concludes that it is too uncertain to reflect such effects adequately in a PNEC. The
Rapporteurs, however, contended that aquatic PNECs, based on both standard AF and SSD
approaches were well supported by reliable experimental data in this case and that in the
absence of any guidance to the contrary, the justification would have to be based on the
available scientific (NP specific) data. The Rapporteurs noted that there were no doubts about
the evidence for the ED properties of NP at least in fish, and that vitellogenin (VTG) induction
and secondary sex characteristics were well known ED indicative endpoints. In this regard, the
SVHC dossier for NP indicates that the lowest reliable ED effect data is for VTG induction in
rainbow trout with a LOEC of 1.05 µg/L. The Rapporteurs noted that VTG induction is an
indicator of endocrine modulation but is per se not necessarily adverse in terms of population
stability. OECD and other test method validation work with small fish species (medaka,
fathead minnow, zebra fish) provide however evidence that in the same treatments of full life
cycle tests, VTG induction during earlier parts of the exposure period precede adverse effects
later on in the same test. For the frequently most sensitive fish species rainbow trout, there is
no adequate full life cycle test available with NP.
The Rapporteurs proposed three options to the Committee on how to deal with ED effects in
terms of the risk assessment: a) by using a lower margin of safety, b) by including an
additional ED assessment factor to the standard PNEC data, or c) by basing the PNEC on
clearly ED indicative endpoints. The Committee supported the option for a lower margin of
safety. Several members pointed out that although there is a working definition for endocrine
disruption, there are no criteria and therefore, the wording in this respect needs to be very
careful.
In relation to environmental hazards of other relevant NPEO degradation products, the
Rapporteurs explained that the submitted dossier refers to evidence showing that ecotoxicity
13
and estrogenicity increase with decreasing chain length, the most toxic substances being those
with one or two ethoxylate or carboxyethoxylate units. This evidence is based on four acute
tests, one chronic Daphnia study, and in vitro receptor binding assays. On this basis,
Environment Canada has derived a Toxic Equivalence Factor (TEF) approach, which has been
proposed in the dossier. The RAC Rapporteurs agree that the TEF would help to estimate
combined effects, however, given the poor data set, they considered that the proposed TEFs
add significant uncertainties to combined hazard estimates – for NP(3-8)EO the Rapporteurs
proposed that QSAR modelling might help to bridge the gap and consolidate the TEFs analysis
(at least for acute toxicity). The Committee supported the proposal of the Rapporteurs. A ‘best
case’ vs ‘worst case’ approach might also be possible as a sensitivity analysis.
NP is a Water Framework Directive (WFD) Priority Hazardous Substance and it is therefore
subject to monitoring by the EU MS. Relevant data have been reported to the Commission and
the dossier submitter has referred to these data to draw conclusions about the risk. Many of
the reported concentrations are below the limit of detection. The dossier submitter used a
median of 'country-specific' PECs, based in turn on a median of 90th percentiles of individual
water bodies, to derive an overall EU PEC of 0.085 µg/L. A similar approach has been used for
the marine PEC (four MSs only) of 0.05 µg/L. In the view of the RAC Rapporteurs this
approach is too simplistic and uncertain for assessing the magnitude or extent of NP
contamination in a risk assessment context. Members of RAC were encouraged, if they have
access to any additional monitoring data, to submit it through the ongoing public consultation
on this restriction proposal. The RAC Rapporteur confirmed that the UK will submit additional
monitoring data via this route. One member confirmed that such data are also available to his
Member State’s competent authority.
With regard to short chain NPEO/NPEC exposure in EU water bodies, the Rapporteurs noted
that the dossier presents data to show that NPEOs degrade to NP and short chain NPEOs in
Waste Water Treatment Plants (WWTP). In the view of the RAC Rapporteurs, the derived ratio
of NP to short chain NPEOs in WWTP effluent is uncertain, and the uncertainty is increased by
the use of the “overall EU PEC” for NP to derive possible concentrations of short chain NPEOs
in receiving waters using this ratio. In addition, the approach assumes that the NP
concentration is solely related to NPEO release, which is not correct based on the evidence of
WWTP influent data. The Rapporteurs explained that hopefully more reliable monitoring
information would help to draw more reliable conclusions about the levels of short chain
NPEOs in receiving waters. Several RAC members supported the Rapporteurs' approach and
highlighted a possibility that industry might also provide some further information through the
public consultation.
With regard to the occurrence of NPEO in textiles, the Rapporteurs informed the participants
that the dossier presents data from 11 studies that clearly show that NPEO is present in some
textile articles, but the representativeness of the data is unknown. The large number of ‘nondetects’ and the large skew in the data make it difficult to decide what an appropriate
'average' measure of NPEO content is. The Rapporteurs asked the RAC members to consult, if
possible, the statisticians in their countries and come up with possible suggestions (also SEAC
will be asked to look into this issue).
For NPEO releases from textile washing, the Rapporteurs noted that they consider the
assumed quantity of NPEO released from textile laundering on an annual basis highly
uncertain. In the dossier, the EU trade statistics (6 million tonnes) and estimated arithmetic
mean concentration (107 mg/kg) are used to derive the likely release of NPEO (642
tonnes/year). However, the Rapporteurs flagged that the figure could be substantially less
(e.g. 60 tonnes/year, if the overall geometric mean concentration in clothing is assumed to
represent textiles in general).
In addition, many other sources of NPEO and NP exist besides textiles (e.g. paints, resins,
construction industry, etc.). The dossier suggests that textile laundering may contribute about
50% of the amount of NP in EU surface waters. Given the large number of untested
assumptions, the comparison of releases of NP/NPEO from different sources is highly
uncertain. The RAC Rapporteurs noted that the assumptions about the relative contribution of
textiles to NP/NPEO concentrations in water bodies are important in the context of the risk
reduction capacity of the proposal. Given the uncertainties, they therefore believe that further
work is needed to establish relative contributions with more confidence before risk reduction
14
capacity can be reliably assessed. A preliminary estimate can be provided by comparing
estimated influent and effluent d concentrations on a per capita release basis with measured
concentrations, but the Rapporteurs would prefer more comprehensive monitoring data to be
available before drawing any conclusions on this issue. Several RAC members expressed
support to the approach proposed by the Rapporteurs.
The Chairman summarised the discussion and encouraged RAC members to provide further
comments to the ongoing written commenting round on the 1 st version of the RAC draft
opinion. The Rapporteurs were asked to take comments into account in the next version of the
RAC draft opinion that would be discussed at the next plenary meeting.
c) 1-Methylpyrrolidin-2-one (NMP) – 1st version of the draft opinion
The Chairman welcomed the dossier submitter representatives (NL) and the SEAC Rapporteurs
who followed the discussion remotely via WebEx. He reminded the Committee that the
restriction dossier on 1-Methyl-2-pyrrolidone (NMP) had been submitted to ECHA in August
2013. The public consultation was launched on 18 September 2013.
The Chairman informed the Committee that ECHA had recently received a letter from the
Commission regarding the NMP restriction proposal referring in particular to the potential
divergence between Derived No Effect Level (DNEL) and the Indicative Occupational Exposure
Level (IOEL). This letter was made available to both RAC and SEAC on 28 November, 2013.
The Chairman invited the Commission observers to introduce this letter and their views to the
participants.
In the view of the Commission, any proposal for adoption of an exposure limit value at an
occupational premise should not be implemented under REACH but under the appropriate
workers' protection legislation, which is specifically designed to establish and implement
IOELs. As REACH does not contain provisions to stop the discussion on the Annex XV dossier,
the proposal should receive a proper assessment by both RAC and SEAC. Based on their final
outcome, the Commission will decide whether the issue needs to be transferred to SCOEL for
further consideration.
The representative of the Commission (DG Employment) confirmed that this issue was also on
the agenda of the 90th meeting of the Scientific Committee on Occupational Exposure Limits
(SCOEL), scheduled for 11 and 12 December 2013. RAC agreed to continue work on this
restriction proposal in the normal way. Several members also highlighted the importance of
communication and collaboration between RAC and SCOEL, to identify potential discrepancies
and find ways to deal with them.
The Rapporteurs presented the 1st version of the draft opinion. In the proposal, the dossier
submitter has used data from the registration dossiers. The dossier submitter had calculated
inhalatory (5 mg/m³) and dermal (2.4 mg/kg bw/day) DNELs, which by comparison with the
exposure estimates of the registration dossiers indicated a risk for most scenarios. In the
dossier, a NOAEC of 247 mg/m³ was set based on a statistically significant 5% decrease of the
foetal body weight at the LOAEC 494 mg/m³. The body weight gain of the dams was
decreased by 19% over the whole gestation period at 247 and 494 mg/m³. The RAC
Rapporteurs explained that they supported 247 mg/m³ as a NOAEC and as the basis for DNEL,
to which the RAC agreed.
The Rapporteurs noted that for intraspecies differences, the dossier submitter used an
assessment factor of 5 for workers, in line with the REACH guidance. For pregnant workers,
however, the same assessment factor was used as normally used for the general population
(i.e., 10), based on the argument that children belong rather to the general population than to
the population of workers. Although the guidance does not specifically mention pregnant
workers; the Rapporteurs supported this approach. RAC discussed the choice of intraspecies
assessment factors for pregnant workers and identified that whereas there is some sympathy
for an AF of 10 for pregnant workers it was not supported by all members, nor is this number
supported by the REACH guidance. It was concluded that the Rapporteurs should for the time
being use both the REACH-supported AF of 5 and the AF of 10 used by the dossier submitter
to illustrate the calculations of the RCRs, and RAC members should provide their comments on
the issue by the 11th December 2013.
15
With regard to exposure, the Rapporteurs explained that the dossier submitter had used data
from the registration dossiers for the different exposure scenarios and gave a brief description
of the input data for the exposure modelling. However, the Rapporteurs questioned how
relevant and reliable the modelled data really were. If the modelling could be interpreted as if
the registration dossiers describe current working practices as far as possible in the exposure
scenarios, then the exposure estimates from the registration dossiers seem to be a proper
basis for the restriction proposal. It was recognised that the range of industrial uses of NMP
was very diverse. On the other hand, it is possible that the exposure scenarios have not been
created based on real workplace information, but rather have been developed using only those
RMMs needed to achieve RCRs<1 and without using higher tier models. It was agreed that the
Rapporteurs would proceed with information from the registration dossiers, acknowledging at
the same time that further information that might affect the exposure assessments might be
received in the public consultation.
Following the request of the RAC members, it was agreed to extend the deadline for the
written commenting round by one day (until 11 December 2013). The Rapporteurs were asked
to take comments into account in the next version of the RAC draft opinion that would be
discussed at the next plenary meeting.
d) Cadmium in paints – outcome of conformity check
The Chairman presented a general approach to the Committee for dealing with an amendment
to an existing restriction entry as requested by the Commission. He noted that it was expected
that other similar ‘amendment’ dossiers may follow in the future. According to legal advice,
non-editorial modifications to an existing Annex XVII entry can only be done via the restriction
procedure initiated by an Annex XV report. Therefore, a standard procedure for conformity
check was launched on 14 November.
The representative of the dossier submitter (ECHA) then presented the main elements of the
proposed restriction to the Committee. The Commission requested ECHA to propose and justify
extending the existing restriction to the placing on the market of paints with certain Integrated
Community Tariff (TARIC) codes. For enforceability reasons, the dossier should also propose
specific limit values of cadmium for such paints.
The ECHA restriction report proposes to modify the restriction such that ‘placing on the
market’ of cadmium in paints, TARIC codes (3208)(3209), would also be restricted if the level
of cadmium in those paints exceeds the limit value of 0.01%. Based on ECHA’s consultation
with the relevant industry representatives it is apparent that concentrations of cadmium in
paints in the EU, including copper-based anti-fouling paints, are currently well below the
proposed concentration limit of 0.01% and are expected to stay so in the future. The positive
limit value allows continuing use of recycled copper and having the same limit value as
elsewhere in the entry simplifies both entry and the enforcement efforts.
The RAC Rapporteur then presented the outcome of the RAC conformity check and
recommended that the dossier should be considered in conformity. He explained that the
amendment of an existing restriction is introduced for enforcement reasons only and there is
no need to re-evaluate the risk by RAC. Some members stated that RAC should not spend too
much time on these types of dossiers; they could be handled for example via written
procedure or other means to process them efficiently.
Following several questions from members, the Chairman confirmed that this case was unique,
as all RAC restrictions so far had involved a full risk assessment. However RAC would assume
that the risk was assessed properly in the first restriction. Only the wording needed to be
amended in the existing entry. The Commission representative noted that the Commission is
content with the approach taken by ECHA.
The Chairman concluded that RAC agreed that the cadmium dossier conforms to the
requirements of Annex XV and thanked the Rapporteur(s) for their presentation of the
arguments and the Committee for their participation in the discussions.
The Secretariat was asked to amend the conformity check template to better reflect the
requirements for any similar amendments to existing restrictions in the future.
16
6.3
Appointment of (co-) Rapporteurs for restriction dossiers
The Secretariat presented the recommendation of the Chairman for the pool of Rapporteurs for
the restriction dossier on Bis(pentabromphenyl) ether (DecaBDE), as well as for the
appointment of (co-) Rapporteurs for chrysotile as outlined in the meeting document
RAC/27/2013/05 CONFIDENTIAL. RAC agreed to the appointment of (co-) Rapporteurs for
chrysotile as proposed in the recommendation.
The Chairman then informed that despite several calls for bisphenol-A (only one volunteer in
the pool) as well as ammonium salts (both dossiers submitted by France) to be submitted in
January 2014, it was not possible to appoint the (co-) Rapporteurs for these dossiers.
Therefore, RAC members were encouraged to come forward urgently for (co-) Rapporteurs of
the restriction dossiers on bisphenol-A and ammonium salts.
7.
Authorisation
7.1 Authorisation application
a) Authorisation application on the use of DEHP in a stop-off formulation in
manufacturing of aero engines – first version of the draft opinion
The Chairman welcomed the RAC Co-Rapporteurs, the SEAC Rapporteur, who was following
the discussion via WebEx, and the Authorisation Team.
The Chairman announced that the discussion on the first version of the draft opinion should
take place in an observed session. However, should a need arise to discuss any confidential
business information, he would close the session as a precaution.
The Rapporteurs then presented the first version of the draft opinion of the application for
authorisation for the processing of a stop-off formulation containing DEHP during the diffusion
bonding and manufacture of aero engine fan blades. Regarding the workplace inhalation
exposure assessment, the Rapporteurs explained that for three out of four contributing
scenarios quantitative inhalation exposure data had been provided: all air concentration
measurements were below the limit of detection. The applicant had used the limit of detection
as the highest “measured” airborne concentration of 10 µg/m³. The Rapporteurs further
elaborated on the workplace dermal exposure assessment, explaining that for three out of four
contributing scenarios, quantitative dermal exposure data had been provided: actual exposure
(wiping of the skin after removal of gloves) being monitored, DEHP was found to be below the
limit of detection of 1 µg in all samples. Thus “actual” exposure per sample could be
considered to be lower than estimated. The Rapporteurs recommended the addition of all
dermal exposure incidents over the full shift by considering all repetitions of the relevant taskbased activity per shift with up to six dermal exposure incidents per activity.
The Rapporteurs noted that the applicant had used the RAC reference DNEL values for
reproductive toxicity and that this gave a combined RCR value of ca. 0.01, which is around
100 times lower than the reference RCR of 1. He also noted that the actual external dermal
exposure RCR value is probably lower than calculated. The Rapporteurs explained that the
possible risks associated with the other components of about 95% of the stop-off formulation
were not considered, since they fell outside the scope of the authorisation procedure; none of
the other components are included in Annex XIV of the REACH Regulation.
The Rapporteurs concluded that in order to control the risks at the workplace the RMMs and
OCs outlined in the application need to be strictly observed.
The RAC concluded that no specific conditions or monitoring arrangements over and above the
RMMs and OCs that have already been included in the application need to be established,
noting a well-controlled workplace, very specific and low quantity usage, the availability of
quantitative monitoring data for inhalation and dermal exposure measured at the facility, and
the fact that very few workers were engaged in these tasks.
17
After a short discussion on the exposure assessment RAC supported the exposure assessment
presented by the co-Rapporteurs and agreed on the exposure values in the Draft Opinion. RAC
considered that adequate control had been demonstrated by the Applicant.
Therefore, RAC agreed the draft opinion on the application for authorisation, recommending
granting of the application.
The Chairman thanked the Rapporteurs for their work and the Committee for their
participation in the discussion.
b) Authorisation applications on Phthalates (submitted within the August
submission window) - outcome of the conformity check
The Rapporteurs briefly presented the following applications for authorisation received by
ECHA:
1) Application for authorisation submitted by ARKEMA FRANCE on the following uses of
Bis(2-ethylhexyl) phthalate (DEHP): Use 1: Formulation of DEHP in compounds, dryblends and Plastisol formulations, Use 2: Industrial use in polymer processing by
calendering, spread coating, extrusion, injection moulding to produce PVC articles
[except erasers, sex toys, household items <10cm, clothing intended to be worn
against bare skin; toys, cosmetics, Food Contact materials (FCM)];
2) Application for authorisation submitted by Grupa Azoty Zakłady Azotowe Kędzierzyn
Spółka Akcyjna on the following uses of DEHP: Use 1: Formulation of DEHP in
compounds, dry-blends and Plastisol formulations, Use 2: Industrial use in polymer
processing by calendering, spread coating, extrusion, injection moulding to produce
PVC articles except erasers, sex toys, household items <10cm, clothing intended to be
worn against bare skin; toys, cosmetics, FCM;
3) Application for authorisation submitted by DEZA a.s. on the following uses of DEHP:
Use 1: Formulation of DEHP in compounds, dry-blends and Plastisol formulations, Use
2: Industrial use in polymer processing by calendering, spread coating, extrusion,
injection moulding to produce PVC articles [except erasers, sex toys, household items
<10cm, clothing intended to be worn against bare skin; toys, cosmetics, FCM], Use 3:
Use in ceramic sheets and printing pastes for production of capacitors and lambda
sensor elements;
4) Application for authorisation submitted by Sasol-Huntsman GmbH & Co. KG on the
following use of dibutyl phthalate (DBP): Use as an absorption solvent in a closed
system in the manufacture of Maleic Anhydride;
5) Application for authorisation submitted by DEZA a.s. on the following uses of DBP: Use
1: Use as an absorption solvent in a closed system in the manufacture of Maleic
Anhydride, Use 2: Use in propellants, Use 3: Use in ceramic sheets and printing pastes
for production of capacitors and lambda sensor elements;
6) Application for authorisation submitted by Roxel (UK Rocket Motors) Ltd on the
following uses of DEHP and DBP: Use 1: Industrial use in manufacture of solid
propellants and motor charges for rockets and tactical missiles (DEHP), Use 2:
Industrial use in manufacture of solid propellants and motor charges for rockets and
tactical missiles (DBP), Use 3: Industrial use within a specialty paint in manufacture of
motors for rockets and tactical missiles (DBP);
7) Application for authorisation submitted by VINYLOOP FERRARA S.p.A., Stena Recycling
AB and Plastic Planet srl on the following uses of DEHP: Use 1: Formulation of recycled
soft PVC containing DEHP in compounds and dry blends, Use 2: Industrial use of
recycled soft PVC containing DEHP in polymer processing by calendering, extrusion,
compression and injection moulding to produce PVC articles;
The RAC agreed with the Rapporteurs that all seven applications for authorisation are in
conformity. The Secretariat will upload the Conformity Reports to the non-confidential part of
CIRCABC and will send them to the applicants.
The teams of Rapporteurs also reported on some issues which could be relevant to the
evaluation of the applications. They will formulate their questions to the applicants for further
18
clarification. The Chairman thanked the Rapporteurs for their presentations and the Committee
for their participation in the discussions.
7.2 Capacity building
a) ECHA project on carcinogenicity dose-response analysis of Cr(VI)-and
inorganic As-containing substances
The ECHA Secretariat presented the outcome of the project and two draft notes concerning the
publication of dose response relationships for Cr(VI)- and inorganic As-containing substances.
The RAC members pointed out that the dose response relationships were derived by linear
extrapolation. Extrapolating outside the range of observation inevitably introduces
uncertainties. As the mechanistic evidence is suggestive of non-linearity, it is acknowledged by
RAC that the excess risks in the low exposure range might be an overestimate.
Moreover, the members recommended adding information to the notes to the effect that it is a
RAC recommendation but that the applicant can deviate from this proposal provided they can
justify it properly.
The RAC agreed on the notes and the Secretariat will upload them on the ECHA website.
b) Trichloroethylene
The invited expert presented the ECHA project: Services to support remaining cancer risks, or
adequate control, related to the use of trichloroethylene in Applications for Authorisation. The
project contains two work packages:

Review the relevant scientific literature related to carcinogenicity of trichloroethylene
and seek information related to cancer mechanisms and exposure

Prepare relevant dose-response curves or threshold-type risk estimates for
trichloroethylene
The presentation of a final report and the end of the project is foreseen in April 2014.
19
7.3 Appointment of (co-) Rapporteurs for authorisation applications
During the plenary meeting the Committee members expressed their interest by applying to
the pool of Rapporteurs and by indicating the absence of conflict of interest. The pool of
Rapporteurs as outlined in the amended confidential room document RAC/27/2013/08 Rev.1
will be agreed in the written procedure after the plenary meeting.
Other issues
As a general comment, a Member suggested to check and decide on the conformity of the
applications for authorisation via a written procedure, instead of discussing them at a plenary
meeting. The Secretariat will consider this suggestion for future applications for authorisation,
bearing in mind that it may be useful to present a brief overview of the application for the
members to familiarise themselves with the case.
With regard to the public consultations on the applications for authorisation, one stakeholder
observer asked ECHA to publish the complete chemical safety report and keep only the
business-threatening information as confidential.
8.
AOB
8.1 Update on Guidance activities
An update on Guidance activities was made available to the members.
20
Part II. Conclusions and action points
MAIN CONCLUSIONS & ACTION POINTS
RAC 27, 2-5 December 2013
(Adopted at the meeting)
Agenda point
Conclusions / agreements / adoptions
Action requested after the meeting
(by whom/by when)
2. Adoption of the Agenda
The Agenda (RAC/A/27/2013) was adopted.
SECR to upload the adopted Agenda to
the RAC CIRCABC and to the ECHA
website as part of the RAC-27 minutes.
3. Declarations of conflicts of interests to the Agenda
SECR informed the Committee on the status of the
discussion of the ECHA Conflicts of Interest Advisory
Committee (CoIAC) on practice of declaring a potential
conflict of interest.
4. Report from other ECHA bodies and activities
4.a. Report on other ECHA bodies
SECR presented document RAC/27/2013/01
4.b. RAC work plan for all processes
SECR presented update on the 2013-2014 work plan for
RAC covering the Classification and Labelling,
Restriction and Authorisation processes.
SECR to inform the RAC on the outcome
of the CoIAC discussion and the decision
of ECHA at RAC 28
SECR to upload the document to the
CIRCABC non-confidential website.
SECR to upload the presentation to nonconfidential folder of the RAC-27 meeting
on CIRCABC.
5. Harmonised classification and labelling (CLH)
5.1. a) Sulfoxaflor
RAC adopted by consensus the opinion with a proposal
for the harmonised classification and labelling as
indicated in Table 1 below.
[Acute Tox. 4 (H302); Acute Aquatic 1 and Chronic 1;
M=1 both; EUH401 (see Art. 25(2) CLP)]
Rapporteurs to revise the opinion in
accordance with the discussions in RAC.
SECR to make an editorial check of the
opinion documents in consultation with
the Rapporteurs.
SECR to forward the adopted opinion and
its annexes to COM and publish it on the
ECHA website.
5.1. b) Phenol, dodecyl-, branched (TPP)
RAC adopted by consensus the two opinions with a
proposal for the harmonised classification and labelling
as indicated in Table 1 below.
Rapporteurs to revise the opinions in
accordance with the discussions in RAC
and to provide them to the SECR.
[Skin Corr. 1C; Repr. 1B (H360F); Aquatic Acute 1 and
Chronic 1; M=10 both]
SECR to make an editorial check of the
opinion documents in consultation with
the Rapporteurs.
SECR to forward the adopted opinions
and their annexes to COM and publish it
on the ECHA website.
5.1. c) Lead
RAC adopted by consensus the opinion with a proposal
for one sole entry in Annex VI pertaining to all forms of
lead, and the harmonised classification and labelling
and specific concentration limits as indicated in Table 1
below.
Rapporteurs to revise the opinion in
accordance with the discussions in RAC.
SECR to make an editorial check of the
opinion documents in consultation with
21
[Repr. 1A, SCLdev=0.03%; Lact.]
the Rapporteurs.
SECR to forward the adopted opinion and
its annexes to COM and to publish it on
the ECHA website.
5.1. d) Anti-coagulant rodenticides
SECR to launch written procedure for the
agreement on environmental hazard
classes of 8 anticoagulant rodenticides.
 brodifacoum (ISO)
RAC agreed on the classification and labelling for
developmental toxicity of brodifacoum (ISO) as
indicated in bold in Table 2 below.
[classification agreed at RAC 27: Repr. 1A; H360D)]
Rapporteur to revise the opinion on
brodifacoum (ISO) in accordance with
the discussion in RAC and to add the
other hazard classes (Acute Tox. and
Skin Sens.) and SCLs for discussion at
the next RAC meeting.
SECR to launch RAC consultation on the
revised draft opinion.
 flocoumafen (ISO)
RAC agreed on the classification and labelling for acute
toxicity and on extension of STOT RE 1 to other routes
of exposure on flocoumafen (ISO) as indicated in bold
in Table 2 below.
[classification agreed at RAC 27: Acute Tox 1; H300,
Acute Tox. 1; H310, Acute Tox. 1; H330]
5.1. e) Triflusulfuron methyl
Rapporteur to revise the opinion on
flocoumafen (ISO) in accordance with the
discussion in RAC and forward it to SECR
for discussion at the next RAC meeting.
SECR to launch RAC consultation on the
revised draft opinion.
RAC adopted by consensus the opinion with a proposal
for the harmonised classification and labelling as
indicated in Table 1 below.
Rapporteurs to revise the opinion in
accordance with the discussion in RAC
and to provide it to the SECR.
[Carc. 2; H351
SECR to make an editorial check of the
opinion documents in consultation with
the Rapporteur.
Aquatic Acute 1; H400, M=100
Aquatic Chronic 1; H410, M=10]
5.1. f) Bifenazate
RAC adopted by consensus the opinion with a proposal
for the harmonised classification and labelling as
indicated in Table 1 below.
[STOT RE 2; H373
Skin Sens. 1; H317 (without subcategory)
Aquatic Acute 1; H400, M=1
Aquatic Chronic 1; H410, M=1]
SECR to forward the adopted opinion and
its annexes to COM and publish it on the
ECHA website.
Rapporteurs to revise the opinion in
accordance with the discussion in RAC
and to provide it to the SECR.
SECR to make an editorial check of the
opinion documents in consultation with
the Rapporteurs.
SECR to forward the adopted opinion and
its annexes to COM and publish it on the
ECHA website.
5.1. g) Fenpyroximate
RAC adopted by consensus the opinion with a proposal
for the harmonised classification and labelling as
indicated in Table 1 below.
Rapporteurs to revise the opinion in
accordance with the discussion in RAC
and to provide it to the SECR.
[Acute Tox. 3; H301
Acute Tox. 2; H330
Skin Sens. 1B ; H317
SECR to make an editorial check of the
opinion documents in consultation with
22
Aquatic Acute 1; H400, M=100
Aquatic Chronic 1; H410, M=1000]
the Rapporteurs.
SECR to forward the adopted opinion and
its annexes to COM and publish it on the
ECHA website.
5.1. h) Lenacil
RAC adopted by consensus the opinion with a proposal
for the harmonised classification and labelling as
indicated in Table 1 below.
[Carc. 2; H351
Aquatic Acute 1; H400, M=10
Aquatic Chronic 1; H410, M=10]
Rapporteur to revise the opinion in
accordance with the discussions in RAC.
SECR to make an editorial check of the
opinion documents in consultation with
the Rapporteur.
SECR to forward the adopted opinion and
its annexes to COM and publish it on the
ECHA website.
5.1. i) Tributyltin compounds
RAC adopted by consensus the opinion with a proposal
for the harmonised classification and labelling as
indicated in Table 1 below.
[Acute Tox.3; H301, Repr. 1B; H360FD]
Rapporteur to revise the opinion in
accordance with the discussion in RAC.
SECR to make an editorial check of the
opinion documents in consultation with
the Rapporteur.
SECR to forward the adopted opinion and
its annexes to COM and publish it on the
ECHA website.
5.2 Appointment of RAC (co-)rapporteurs for CLH dossiers
Call for expression of interest of (co-)rapporteurship for SECR to upload the list of appointed (coCLH dossiers listed in document RAC/27/2013/02 )rapporteurs to CIRCABC confidential.
(CONFIDENTIAL room document)
6. Restrictions
6.1 General Restriction Issues
6.1.b) Revision of the restriction process
RAC agreed on the revised working procedure on
conformity check of Annex XV restriction dossiers with
one additional modification (12 days for initial
commenting round).
SECR to upload the revised procedure to
CIRCABC and to apply it starting from
restriction dossiers submitted within the
January 2014 submission window.
SECR to revise the opinion development
procedure and table it for agreement at
RAC-28.
6.2 Restriction Annex XV dossiers
6.2.a) Lead in consumer articles – 4th version of the RAC draft opinion
RAC Rapporteurs presented the modified fourth version
of the RAC opinion.
RAC discussed the main changes made to the draft
opinion of RAC.
RAC adopted the opinion on the proposed restriction by
simple majority. Dissenting views will be reflected in
the RAC27 minutes.
Rapporteurs to make final editorial
changes to the justification of the opinion
based on the discussions held at RAC-27.
Rapporteurs
to
ensure
that
the
supporting
documentation
(BD
and
RCOM) is in line with the adopted RAC
opinion.
SECR to launch an urgent written
procedure for the adoption of the
justification.
SECR to forward the adopted opinion and
23
its supporting documentation to SEAC.
SECR to publish the adopted opinion and
its supporting documentation on the
ECHA website and CIRCABC IG.
6.2.b) Nonylphenol - 1st version of the draft opinion
RAC Rapporteurs presented the 1st version of the RAC
draft opinion.
Rapporteurs to take comments into
account in the 2nd version of the draft
opinion (due by mid-February 2014).
Rapporteurs in cooperation with the
SECR to submit a response to comments
for distribution to RAC members.
6.2.c) 1-Methylpyrrolidin-2-one (NMP) - 1st version of the draft opinion
RAC Rapporteurs presented the 1st version of the RAC
draft opinion.
Rapporteurs to take comments into
account in the 2nd version of the draft
opinion (due by mid-February 2014).
Rapporteurs in cooperation with the
SECR to submit a response to comments
for distribution to RAC members.
6.2.d) Cadmium
conformity check
in
paints
–
outcome
of
RAC agreed that the dossier conforms to the Annex XV
requirements and took note of the recommendations to
the dossier submitter.
SECR to compile the RAC and SEAC final
outcomes of the conformity check and
upload this to CIRCABC.
SECR to inform the dossier submitter on
the outcome of the conformity check.
SECR
to
consider
amending
the
conformity check template for future
purposes to be used for similar dossiers.
7. Authorisation
7.1 Authorisation applications
7.1.a) Authorisation application on the use of DEHP in a stop-off formulation in manufacturing of
aero engines – first version of the draft opinion
RAC supported the exposure assessment presented by
the co-rapporteurs and agreed on the exposure values
in the Draft Opinion.
SECR to send the Applicant the Draft
Opinion with a request to indicate his
intention to submit comments on the
Draft Opinion.
RAC supported that DEHP is a threshold substance, and
adequate control has been demonstrated by the
Applicant.
Option 1: Should the Applicant not wish
to comment or fails to comment by the
deadline (2 months), the RAC Chairman
to approve the Final Opinion on behalf of
RAC.
RAC agreed to recommend granting the authorisation in
accordance with the application has been made to the
Commission.
SECR to send the Opinion to the
Commission, the Member States and the
Applicant.
SECR to publish the Opinion on the ECHA
website.
Option 2: Should the Applicant wish to
comment, SECR to make the Applicant’s
comments available on CIRCABC and to
24
inform RAC.
SECR to invite the co-rapporteurs to
provide their views on the comments.
Co-rapporteurs
to
preview
the
Applicant’s comments and to prepare a
draft version of the Final Opinion taking
into account the Applicant’s comments,
and to send it to SECR.
SECR to organise written commenting in
RAC.
Co-rapporteurs to revise the draft Final
Opinion.
SECR to initiate the adoption of the Final
Opinion at the RAC plenary meeting or
via written procedure.
7.1.b) Authorisation applications on Phthalates (submitted within the August submission window) outcome of the conformity check
Rapporteurs presented seven applications for
authorisation (DEHP and DBP) and the draft conformity
reports.
SECR to upload the adopted Conformity
Report for the first application for
authorisation on CIRCA BC.
RAC agreed on the conformity of all seven applications
for authorisation.
SECR to send the updated Conformity
Report to the Applicant.
7.2 Capacity building
7.2.a) ECHA project on carcinogenicity dose-response
analysis of Cr (VI)-and As-containing substances
SECR to upload the document on ECHA
website.
7.2.b) ECHA project on carcinogenicity dose response
analysis of Trichloroethylene
9. Action points and main conclusions of RAC-27
SECR to upload the adopted action points
to CIRCABC.
25
Table 1. Adopted by RAC 27 - proposed new or revised classification in Annex VI, CLP1
Sulfoxaflor
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Index
No
Current
Annex VI
entry
Dossier
submitters
proposal
RAC
opinion
Resulting
Annex VI
entry if
agreed by
COM
International
Chemical
Identification
EC No CAS
No
Classification
Hazard Class
and Category
Code(s)
Labelling
Hazard
statement
Code(s)
Pictogram
, Signal
Word
Code(s)
Hazard
statement
Code(s)
Specific
Conc.
Limits,
Suppl.
MHazard
statement factors
Code(s)
Notes
No current Annex VI entry
-
946578- Acute Tox. 4
00-3
Aquatic Acute 1
Aquatic Chronic 1
H302
H400
H410
GHS07
GHS09
Wng
H302
H410
M=1
M=1
sulfoxaflor (ISO); [methyl(oxo){1-[6616-217- (trifluoromethyl)-300-4
pyridyl]ethyl}-λ6sulfanylidene]cyana
mide
-
946578- Acute Tox. 4
00-3
Aquatic Acute 1
Aquatic Chronic
1
H302
H400
H410
GHS07
GHS09
Wng
H302
H410
M=1
M=1
946578- Acute Tox. 4
00-3
Aquatic Acute 1
Aquatic Chronic 1
H302
H400
H410
GHS07
GHS09
Wng
H302
H410
M=1
M=1
1
Hazard classes, category and hazard statement codes are written in bold if they were agreed by RAC during the meeting. Discussions on other hazard classes highlighted in yellow
are still on-going.
26
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index
No
Current
Annex VI
entry
Dossier
submitters
proposal
RAC
opinion
Resulting
Annex VI
entry if
agreed by
COM
International
Chemical
Identification
EC No
CAS No
Classification
Labelling
Concentration
Limits
Notes
No current Annex VI entry
-
sulfoxaflor (ISO);
[methyl(oxo){1-[6616-217- (trifluoromethyl)-300-4
pyridyl]ethyl}-λ6sulfanylidene]cyana
mide
-
94657800-3
Xn; R22
N; R50-53
Xn; N
R: 22-50/53
S: (1/2-)46-60-61
N; R50/53: C ≥ 25
%
N; R51/53: 2,5 %
≤ C < 25 %
R52/53: 0,25 % ≤
C < 2,5 %
94657800-3
Xn; R22
N; R50-53
Xn; N
R: 22-50/53
S: (2-)60-61
94657800-3
Xn; R22
N; R50-53
Xn; N
R: 22-50/53
S: (2-)60-61
N; R50-53: C ≥
25 %
N; R51-53: 2,5 %
≤ C < 25 %
R52-53: 0,25 %
≤ C < 2,5 %
N; R50-53: C ≥ 25
%
N; R51-53: 2,5 %
≤ C < 25 %
R52-53: 0,25 % ≤
C < 2,5 %
27
Lead
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Classification
Index
No
International
Chemical
Identification
EC No
CAS No
Hazard Class
and Category
Code(s)
Current
Annex VI
entry
Resulting
Annex VI
entry if
agreed by
COM
Pictogram
, Signal
Word
Code(s)
Hazard
statement
Code(s)
Suppl.
Hazard
statement
Code(s)
Specific Conc.
Limits, Mfactors
Note
s
No current Annex VI entry
Dossier
submitters
proposal
RAC
opinion
Hazard
statement
Code(s)
Labelling
082013-001
lead
231-1004
743992-1
Repr. 1A
H360FD
GHS08
Dgr
H360FD
Repr. 1A
Lact.
H360FD
H362
GHS08
Dgr
H360FD
H362
Repr. 1A
Lact.
H360FD
H362
GHS08
Dgr
H360FD
H362
Repr. 1A;
H360FD: C ≥ 0,03
%
Repr. 1A;
H360D: C ≥ 0,03
%
Repr. 1A; H360D:
C ≥ 0,03 %
28
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index
No
International
Chemical
Identification
EC No
CAS No
Classification
Current
Annex VI
entry
Resulting
Annex VI
entry if
agreed by
COM
Concentration Limits
Notes
No current Annex VI entry
Dossier
submitters
proposal
RAC
opinion
Labelling
Repr. Cat. 1; R60-61
Repr. Cat. 1; R60-61
082-01300-1
lead
231-100-4
7439-92- R64
1
Repr. Cat. 1; R60-61
R64
T
R: 60-61
S: (1/2-)13-35-45-53
Repr. Cat. 1; R60-61: C ≥
0,03 %
T
R: 60-61-64
S:45-53
Repr. Cat. 1; R61: C ≥
0,03 %
T
R: 60-61-64
S: 45-53
Repr. Cat. 1; R61: C ≥
0,03 %
29
Phenol, dodecyl-, branched
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Inde International
x No Chemical
Identification
Current
Annex VI
entry
Dossier
submitters
proposals
(denoted as
(1) and (2))
RAC opinion
Resulting
Annex VI
entry if
agreed by
COM
EC No
CAS No
Classification
Hazard Class
and Category
Code(s)
Labelling
Hazard
statement
Code(s)
Pictogram,
Hazard
Signal Word stateCode(s)
ment
Code(s)
Specific
Conc.
Limits,
Suppl.
Hazard Mstateme factors
nt
Code(s)
Notes
No current Annex VI entry
60409200-9
Phenol, dodecyl-,
branched [1];
Phenol, 2-dodecyl-,
branched;
310Phenol, 3-dodecyl-,
154-3
branched;
[1]
Phenol, 4-dodecyl-,
branched;
Phenol, (tetrapropenyl)
derivatives [2]
121158-585 [1]
74499-35-7
[2]
Repr. 2 (1)
Repr. 1B (2)
Skin Irrit. 2 (1)
Eye Irrit. 2 (1)
Aquatic Acute 1
(1)
Aquatic Chronic 1
(1)
Repr. 1B
Skin Corr. 1C
Aquatic Acute 1
Aquatic Chronic
1
Repr. 1B
Skin Corr. 1C
Aquatic Acute 1
Aquatic Chronic 1
H361f (1)
H360F (2)
H315 (1)
H319 (1)
H400 (1)
H410 (1)
GHS08 (1),(2)
GHS07 (1)
GHS09 (1)
Wng (1)
Dgr (2)
H361f (1)
H360F (2)
H315 (1)
H319 (1)
H410 (1)
Repr. 1B;
H360F: C
≥ 1,5 %
(2)
M=1 (1)
M=10 (1)
H360F
H314
H400
H410
GHS05
GHS08
GHS09
Dgr
H360F
H314
H410
M=10
M=10
H360F
H314
H400
H410
GHS05
GHS08
GHS09
Dgr
H360F
H314
H410
M=10
M=10
30
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index
No
International
Chemical
Identification
EC No
Current
Annex VI
entry
Dossier
submitters
proposal
RAC
opinion
Resulting
Annex VI
entry if
agreed by
COM
CAS No
Classification
Labelling
Concentration Limits Notes
C, Xn, N (1)
T (2)
R: 36/38-62(1)50/53 (1)
R: 60 (2)
S: 26-36/37/39-6061
N; R50-53: C ≥ 25 %
N; R51-53: 2,5 % ≤ C <
25%
R52-53: 0,25 % ≤ C <
2,5 % (1)
No current Annex VI entry
Repr. Cat. 3 (1)
Repr. Cat. 2 (2)
Xi; R36-38 (1)
N; R50-53 (1)
Phenol, dodecyl-,
branched [1];
Phenol, 2-dodecyl-,
branched;
604-092Phenol, 3-dodecyl-,
00-9
branched;
Phenol, 4-dodecyl-,
branched;
Phenol, (tetrapropenyl)
derivatives [2]
310-154-3
[1]
121158-58-5
Repr. Cat. 2; R60
[1]
C; R34
74499-35-7 [2] N; 50-53
Repr. Cat. 2; R60
C; R34
N; 50-53
C, T, N
R: 34-50/53-60
S: 26-36/37/3945-53-60-61
C, T, N
R: 34-50/53-60
S: 26-36/37/39-4553-60-61
Repr. Cat. 2; R60: C <
1,5 % (2)
N; R50-53: C ≥ 2,5 %
N; R51-53: 0,25 % ≤ C <
2,5 %
R52-53: 0,025 % ≤ C <
0,25 %
N; R50-53: C ≥ 2,5 %
N; R51-53: 0,25 % ≤ C <
2,5 %
R52-53: 0,025 % ≤ C <
0,25 %
31
Flocoumafen
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Classification
Index No
International
Chemical
Identification
EC No
CAS No
Hazard Class
and Category
Code(s)
Acute Tox. 2 *
Acute Tox. 1
Current
Annex VI
entry
5 reaction mass of: cis4-hydroxy- 3-(1,2,3,4tetrahydro-3-(4-(4trifluoromethylbenzylox
y)phenyl)-1naphthyl)coumarin;
607-375-00-5
trans-4-hydroxy-3(1,2,3,4- tetrahydro-3(4-(4trifluoromethylbenzylox
Dossier
y)phenyl)-1submitters
naphthyl)coumarin
proposal
Acute Tox. 2 *
STOT RE 1
Aquatic Acute 1
Aquatic Chronic 1
421-960-0
90035-08-8
Labelling
Pictog
Hazard
ram,
stateme Signal
nt
Word
Code(s) Code(
s)
H330
H310
H300
H372 **
H400
Suppl.
Hazar
Hazard
d
statestate
ment
ment
Code(s)
Code(
s)
Specific
Conc.
Limits, Mfactors
Not
es
GHS06 H330
GHS08
H310
GHS09
H300
Dgr
H372 **
H410
H410
Add:
Add:
Add:
Add:
Repr. 2
H361d
H361d
Modify:
Modify:
Acute Tox. 1
H330
Remove:
STOT RE 1;
H372: C ≥
0,05 %
Acute Tox. 1
H300
**for
H372
Remove:
**for
STOT RE 2;
H373:
0,005 % ≤ C
< 0,05 %
32
H372
Repr.
2;H361d:
C≥0.003%
M=10
M=10
Add:
Repr. 2
Modify:
RAC
opinion
Acute Tox. 1
Acute Tox. 1
STOT RE 1;
H372: C ≥
0,05 %
Add:
H361d
Add:
Modify:
H361d
H330
H300
Remove:
Remove:
**for
H372
**for
H372
STOT RE 2;
H373:
0,005 % ≤ C
< 0,05 %
Repr.
2;
H361d: C ≥
0,003 %
M=10
M=10
Resulting
Annex VI
entry if
agreed by
COM
STOT RE 1;
H372: C ≥
0,05 %
STOT RE 2;
H373:
0,005 % ≤ C
< 0,05 %
Repr. 2
H361d
GHS06
Acute Tox. 1
H330
GHS08
Acute Tox. 1
H310
Acute Tox 1
H300
STOT RE 1
H372
Aquatic Acute 1
H400
H372
Repr.
2;
H361d: C ≥
0,003 %
Aquatic Chronic 1
H410
H410
M=10
GHS09
Dgr
H361d
H330
H310
H300
M=10
33
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index
No
International
Chemical
Identification
EC No
CAS No
Classification
Labelling
Concentration
Limits
Notes
Current
Annex VI
entry
Dossier
submitters
proposal
RAC
opinion
Resulting
Annex VI
entry if
agreed by
COM
34
Brodifacoum
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Classification
Index
No
International
Chemical
Identification
EC No
Hazard Class and
Category Code(s)
Acute Tox. 1
Acute Tox. 2 *
STOT RE 1
Aquatic Acute 1
Aquatic Chronic 1
Current
Annex VI
entry
4-hydroxy-3-(3-(4'bromo-4biphenylyl)Dossier
607-172- 1,2,3,4-tetrahydrosubmitters
100-1
proposal
naphthyl)coumarin;
Brodifacoum (ISO)
CAS
No
259980-5
2
56073- Add: Repr. 1B
10-0
Modify : Acute Tox. 1
Hazard
statement
Code(s)
H310
H300
H372**
H400
H410
Labelling
Pictogram
, Signal
Word
Code(s)
GHS06
GHS08
GHS09
Dgr
Hazard
statement
Code(s)
Suppl.
Hazar
d
statem
ent
Code(
s)
Specific
Conc.
Limits, Mfactors
No
tes
H310
H300
H372 **
H410
H360D
H360D
H300
H300
Add: Acute Tox. 1
H330
H330
Add : Skin Sens 1
H317
H317
Remove:
Remove:
**for H372
**for H372
Add:
STOT RE 1;
H372: C ≥
0,25 %
STOT RE 2;
H373: 0,025
% ≤ C < 0,25
%
M=10
M=10
2
After the public consultation of the proposal, the dossier submitter revised their proposal to Repr. 1A; H360D.
35
RAC
opinion
Add: Repr. 1A
H360D
H360D
Modify : Acute Tox. 1
H300
H300
Add: Acute Tox. 1
H330
H330
Add : Skin Sens 1
H317
Remove:
H317
Remove:
**for H372
**for H372
Add:
STOT RE 1;
H372: C ≥
0,25 %
STOT RE 2;
H373: 0,025
% ≤ C < 0,25
%
M=10
M=10
Resulting
Annex VI
entry if
agreed by
COM
Repr. 1A
Acute Tox. 1
Acute Tox. 1
Acute Tox. 1
STOT RE 1
Skin Sens 1
Aquatic Acute 1
Aquatic Chronic 1
H360D
H310
H300
H330
H372
H317
H400
H410
GHS06
GHS08
GHS09
Dgr
H360D
H310
H300
H330
H372
H317
H410
STOT RE 1;
H372: C ≥
0,25 %
STOT RE 2;
H373: 0,025
% ≤ C < 0,25
%
M=10
M=10
36
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index
No
International
Chemical
Identification
EC No
CAS No
Classification
Labelling
Concentration
Limits
Notes
Current
Annex VI
entry
Dossier
submitters
proposal
RAC
opinion
Resulting
Annex VI
entry if
agreed by
COM
37
Triflusulfuron methyl
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Index No
International
Chemical
Identification
EC No
Current
Annex
VI
entry
Dossier
submitters
proposal
triflusulfuronmethyl; methyl 2({[4RAC opinion
(dimethylamino)-6607-714(2,2,200-7
trifluoroethoxy)1,3,5-triazin-2Resulting
yl]carbamoyl}sulfa
Annex
VI
moyl)-3entry
if
methylbenzoate
agreed
by
CAS No
Classification
Labelling
Hazard Class and Hazard
Category Code(s)
statement
Code(s)
Pictogram,
Hazard
state- Suppl.
Signal Word ment Code(s)
Hazard
Code(s)
statement
Code(s)
Specific
Notes
Conc.
Limits, Mfactors
No current Annex VI entry
Carc. 2
Aquatic Acute 1
Aquatic Chronic 1
N/A
Carc. 2
126535- Aquatic Acute 1
Aquatic Chronic 1
15-7
Carc. 2
Aquatic Acute 1
Aquatic Chronic 1
H351
H400
H410
GHS08
GHS09
Wng
H351
H410
M=100
M=10
H351
H400
H410
GHS08
GHS09
Wng
H351
H410
M=100
M=10
H351
H400
H410
GHS08
GHS09
Wng
H351
H410
M=100
M=10
-
-
-
COM
38
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index No
International
Chemical
Identification
EC No
CAS No
Current
Annex
VI
entry
Dossier
submitters
proposal
Labelling
Concentration Limits
Notes
No current Annex VI entry
Carc. Cat. 3; R40
N; R50-53
RAC opinion
607-71400-7
Resulting
Annex
VI
entry
if
agreed
by
COM
Classification
triflusulfuronmethyl; methyl 2({[4(dimethylamino)-6(2,2,2trifluoroethoxy)1,3,5-triazin-2yl]carbamoyl}sulfa
moyl)-3methylbenzoate
Carc. Cat. 3; R40
N; R50-53
N/A
126535-157
Carc. Cat. 3; R40
N; R50-53
Xn; N
R: 40-50/53
S: 36/37-60-61
Xn; N
R: 40-50/53
S: (2-)36/37-60-61
Xn; N
R: 40-50/53
S: (2-)36/37-60-61
N; R50-53: C ≥ 0,25 %
N; R51-53: 0,025 % ≤
C < 0,25 %
R52-53: 0,0025 % ≤ C
< 0,025 %
N; R50-53: C ≥ 0,25
%
N; R51-53: 0,025 % ≤
C < 0,25 %
R52-53: 0,0025 % ≤
C < 0,025 %
N; R50-53: C ≥ 0,25 %
N; R51-53: 0,025 % ≤
C < 0,25 %
R52-53: 0,0025 % ≤ C
< 0,025 %
-
-
-
39
Bifenazate
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Index No
International
Chemical
Identification
EC No
Current
Annex
VI
entry
Dossier
submitters
proposal
RAC opinion
Resulting
Annex
VI
entry
if
agreed
by
COM
CAS No
Classification
Labelling
Hazard Class and Hazard
Category Code(s) statement
Code(s)
Pictogram,
Hazard
state- Suppl.
Signal Word ment Code(s)
Hazard
Code(s)
statement
Code(s)
Specific
Notes
Conc.
Limits, Mfactors
No current Annex VI entry
STOT RE 2
Skin Sens. 1B
Aquatic Acute 1
Aquatic Chronic 1
bifenazate (ISO);
Isopropyl 2-(4607-715442methoxybiphenyl-300-2
820-5
yl)hydrazinecarboxy
late
STOT RE 2
149877- Skin Sens. 1
Aquatic Acute 1
41-8
Aquatic Chronic
1
STOT RE 2
Skin Sens. 1
Aquatic Acute 1
Aquatic Chronic 1
H373
H317
H400
H410
GHS07
GHS08
GHS09
Wng
H373
H317
H410
M=1
M=1
H373
H317
H400
H410
GHS07
GHS08
GHS09
Wng
H373
H317
H410
M=1
M=1
H373
H317
H400
H410
GHS07
GHS08
GHS09
Wng
H373
H317
H410
M=1
M=1
40
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index No
International
Chemical
Identification
EC No
Current
Annex
VI
entry
Dossier
submitters
proposal
Classification
Labelling
Concentration Limits
Notes
No current Annex VI entry
RAC opinion
607-71500-2
Resulting
Annex
VI
entry
if
agreed
by
COM
CAS No
bifenazate (ISO);
Isopropyl 2-(4methoxybiphenyl-3yl)hydrazinecarboxy
late
442820-5
R43
N; R50/53
Xi; N
R: 43-50/53
S: 24-37-60-61
N; R50/53: C ≥ 25 %
N; R51/53: 2,5 % ≤ C < 25
%
N; R52/53: 0,25 % ≤ C <
2,5 %
R43
Xi; N
R: 43-50/53
S: (2-)24-37-60-61
N; R50-53: C ≥ 25 %
N; R51-53: 2,5 % ≤ C <
25 %
N; R52-53: 0,25 % ≤ C <
2,5 %
R43
N; R50-53
Xi; N
R: 43-50/53
S: (2-)24-37-60-61
N; R50/53: C ≥ 25 %
N; R51/53: 2,5 % ≤ C < 25
%
N; R52/53: 0,25 % ≤ C <
2,5 %
149877-41- N; R50-53
8
41
Fenpyroximate
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Index No
Current
Annex
entry
International
Chemical
Identification
EC No
VI
Resulting
Annex VI
entry
if
agreed by
COM
Classification
Labelling
Hazard Class and Hazard
Category Code(s) statement
Code(s)
Pictogram,
Hazard
state- Suppl.
Signal Word ment Code(s)
Hazard
Code(s)
statement
Code(s)
Specific
Notes
Conc.
Limits, Mfactors
No current Annex VI entry
Dossier
submitters
proposal
RAC
opinion
CAS No
fenpyroximate
(ISO);
tert-butyl 4-[({(E)[(1,3-dimethyl-5607-713phenoxy-1H00-1
pyrazol-4yl)methylene]amino
}oxy)methyl]benzo
ate
Acute Tox. 3
Acute Tox. 2
Eye Irrit. 2
Skin Sens. 1B
Aquatic Acute 1
Aquatic Chronic 1
-
Acute Tox. 3
Acute Tox. 2
134098Skin Sens. 1B
61-6
Aquatic Acute 1
Aquatic Chronic
1
Acute Tox. 3
Acute Tox. 2
Skin Sens. 1B
Aquatic Acute 1
Aquatic Chronic 1
H301
H330
H319
H317
H400
H410
GHS06
GHS07
GHS09
Dgr
H301
H330
H319
H317
H410
H301
H330
H317
H400
H410
GHS06
GHS09
Dgr
H301
H330
H317
H410
M=100
M=1000
H301
H330
H317
H400
H410
GHS06
GHS09
Dgr
H301
H330
H317
H410
M=100
M=1000
M=100
M=1000
42
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index No
Current
Annex
VI
entry
Dossier
submitters
proposal
EC No
CAS No
Classification
Labelling
Concentration Limits
Notes
No current Annex VI entry
RAC opinion
607-71300-1
Resulting
Annex
VI
entry
if
agreed
by
COM
International
Chemical
Identification
fenpyroximate
(ISO);
tert-butyl 4-[({(E)[(1,3-dimethyl-5phenoxy-1Hpyrazol-4yl)methylene]amino
}oxy)methyl]benzoa
te
-
Xn; R22
T+; R26
R43
N; R50-53
T+; R26
134098-61- Xn; R22
6
R43
N; R50-53
T+; R26
Xn; R22
R43
N; R50-53
T+; N
R: 22-26-43-50/53
T+; N
R: 22-26-43-50/53
S: (1/2-)28-36/37-4560-61-63
T+; N
R: 22-26-43-50/53
S: (1/2-)28-36/37-45-6061-63
43
Tributyltin compounds
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Index No
Current
Annex
entry
VI
International
Chemical
Identification
tributyltin
compounds, with
the exception of
those specified
elsewhere in this
annex
EC No
-
CAS No
-
Dossier
submitters
proposal
-
RAC opinion
Resulting
Annex
VI
entry
if
agreed
by
COM
-
050-00800-3
tributyltin
compounds, with
the exception of
those specified
elsewhere in this
annex
-
-
-
-
Classification
Labelling
Hazard Class and Hazard
Category Code(s) statement
Code(s)
Pictogram,
Hazard
Signal
Word stateCode(s)
ment
Code(s)
Suppl.
Hazard
statement
Code(s)
Acute Tox. 3 *
Acute Tox. 4 *
STOT RE 1 **
Skin Irrit. 2
Eye Irrit. 2
Aquatic Acute 1
Aquatic Chronic 1
H301
H312
H372
H315
H319
H400
H410
GHS06
GHS08
GHS09
Dgr
H301
H312
H372**
H315
H319
H410
-
Add
Repr. 1B
Add
H360Fd
Add
H360Fd
Modify
Acute Tox. 3
Acute Tox. 3
Modify
H301
H311
GHS06
GHS08
GHS09
Dgr
Add
Repr. 1B
Add
H360FD
Add
H360FD
Modify
Acute Tox. 3
Modify
H301
GHS06
GHS08
GHS09
Dgr
Retain
Acute Tox. 4 *
Retain
H312
Repr. 1B
Acute Tox. 3
Acute Tox. 4*
STOT RE 1
Skin Irrit. 2
Eye Irrit. 2
H360FD
H301
H312
H372**
H315
H319
Specific Conc. Limits, Notes
Mfactors
*
STOT RE 1; H372: C
≥1%
STOT RE 2; H373:
A
0,25 % ≤ C < 1 %
1
Skin Irrit. 2; C ≥ 1 %
Eye Irrit. 2; C ≥ 1 %
M=10
Modify
H301
H311
Modify
H301
Retain
H312
GHS06
GHS08
GHS09
Dgr
H360FD
H301
H312
H372**
H315
H319
-
*
STOT RE 1; H372: C
≥1%
A
STOT RE 2; H373:
1
0,25 % ≤ C < 1 %
Skin Irrit. 2; C ≥ 1 %
44
Aquatic Acute 1
Aquatic Chronic 1
H400
H410
H410
Eye Irrit. 2; C ≥ 1 %
M=10
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index No International
Chemical
Identification
Current
Annex
entry
EC No
CAS No
VI
tributyltin
compounds, with
the exception of
those specified
elsewhere in this
annex
-
Classification
Labelling
Concentration Limits
Notes
T; R25-48/23/25
Xn; R21
Xi; R36/38
N; R50-53
T; N
R: 21-25-36/38-48/23/2550/53
S: (1/2-)36/37/39-45-6061
A
1
Add
Add
R: 60-63
T; R25: C ≥ 2,5 %
Xn; R22: 0,25 % ≤ C < 2,5 %
Xn: R21: C ≥ 1 %
T; R48/23/25: C ≥ 1 %
Xn; R48/20/22: 0,25 % ≤ C < 1
%
Xi; R36/38: C ≥ 1 %
N; R50-53: C ≥ 2,5 %
N; R51-53: 0,25 % ≤ C < 2,5 %
R52-53: 0,025 % ≤ C < 0,25 %
T; R25: C ≥ 2,5 %
Xn; R22: 0,25 % ≤ C < 2,5 %
Xn: R21: C ≥ 1 %
T; R48/23/25: C ≥ 1 %
Xn; R48/20/22: 0,25 % ≤ C < 1
%
Xi; R36/38: C ≥ 1 %
N; R50-53: C ≥ 2,5 %
N; R51-53: 0,25 % ≤ C < 2,5 %
R52-53: 0,025 % ≤ C < 0,25 %
T; R25: C ≥ 2,5 %
Xn; R22: 0,25 % ≤ C < 2,5 %
Xn: R21: C ≥ 1 %
T; R48/23/25: C ≥ 1 %
Xn; R48/20/22: 0,25 % ≤ C < 1
%
Xi; R36/38: C ≥ 1 %
N; R50-53: C ≥ 2,5 %
N; R51-53: 0,25 % ≤ C < 2,5 %
A
1
-
Dossier
submitters
proposal
Repr. Cat. 22; R60
-
-
Repr. Cat. 3; R63
050-00800-3
RAC opinion
Resulting
Annex
VI
entry
if
agreed
by
COM
tributyltin
compounds, with
the exception of
those specified
elsewhere in this
annex
-
-
Add
Add
Repr. Cat. 2; R60
R: 60-63
Repr. Cat. 3; R63
-
-
Repr. Cat. 2; R60
Repr. Cat. 3; R63
T; R25-48/23/25
Xn; R21
Xi; R36/38
N; R50-53
T; N
R: 21-25-36/38-48/23/2550/53-60-63
S: 36/37/39-45-53-60-61
45
R52-53: 0,025 % ≤ C < 0,25 %
46
Lenacil
Classification and labelling in accordance with the CLP Regulation (Regulation (EC) 1272/2008)
Index No
Current
Annex
VI
entry
Dossier
submitters
proposal
International
Chemical
Identification
lenacil (ISO);
3-cyclohexyRAC opinion
6,7-dihydro613-3201H00-6
cyclopenta[d]p
yrimidineResulting
2,4(3H,5H)Annex
VI
entry
if
dione
agreed
COM
by
EC No
CAS No
Classification
Labelling
Hazard Class and Hazard
Category Code(s) statement
Code(s)
Pictogram,
Hazard
state- Suppl.
Signal Word ment Code(s)
Hazard
Code(s)
statement
Code(s)
Specific
Notes
Conc.
Limits, Mfactors
No current Annex VI entry
218499-0
Aquatic Acute 1
2164-08Aquatic Chronic 1
1
H400
H410
GHS09
Wng
H410
M=10
M=10
218499-0
Carc. 2
2164-08Aquatic Acute 1
1
Aquatic Chronic 1
H351
H400
H410
GHS08
GHS09
Wng
H351
H410
M=10
M=10
Carc. 2
2164-08- Aquatic Acute 1
Aquatic Chronic 1
1
H351
H400
H410
GHS08
GHS09
Wng
H351
H410
M=10
M=10
218499-0
47
Classification and labelling in accordance with the criteria of Directive 67/548/EEC (DSD)
Index No International
Chemical
Identification
Current
Annex
VI
entry
Dossier
submitters
proposal
CAS No
Classification
Labelling
Concentration Limits Notes
No current Annex VI entry
218-499-0
RAC opinion
613-32000-6
Resulting
Annex
VI
entry
if
agreed
by
COM
EC No
lenacil (ISO);
3-cyclohexy6,7-dihydro1Hcyclopenta[d]p
yrimidine2,4(3H,5H)dione
218-499-0
218-499-0
N; R50-53
N
R: 50/53
S: 35-57
N; R50-53: C ≥ 2,5%
N; R51-53: 0,25% ≤ C
<2,5%
R52-53: 0,025% ≤ C
< 0,25%
Carc. Cat. 3; R40
N; R50-53
Xn; N
R: 40-50/53
S: (2-)36/37-60-61
N; R50-53: C ≥ 2,5
%
N; R51-53: 0,25 %
≤ C <2,5 %
R52-53: 0,025 % ≤
C < 0,25 %
Carc. Cat. 3; R40
N; R50-53
Xn; N
R: 40-50/53
S: (2-)36/37-60-61
2164-08-1
2164-08-1
2164-08-1
48
Part III. List of Attendees of the RAC-27 meeting
02-05 December 2013
RAC members
ECHA staff
BARANSKI Bogusław
ATLASON Palmi
BARRON Thomasina
BERGES Markus
BIRO Anna
BLAINEY Mark
BJORGE Christine
BOWMER Tim, Chairman
BRANISTEANU Radu
BROECKAERT Fabrice
CARVALHO João
DE BRUIJN Jack
Di PROSPERO FANGHELLA Paola
DVORAKOVA Dana
DUNAUSKIENĖ Lina
ERICSSON Gunilla
DUNGEY Stephen
FUHRMANN Anna
GREIM Helmut (2-3.12)
HELLSTEN Kati
GRUIZ Katalin
HONKANEN Jani
HAKKERT Betty
JOVER BUSTILLO Vanessa
ILIE Mihaela
KANELLOPOULOU Athanasia
JENSEN Frank
KARJALAINEN Ari
KADIĶIS Normunds
KLAUK Anja
KAPELARI Sonja
KOKKOLA Leila
KORATI Safia
KOSK-BIENKO Joanna
LEINONEN Riitta
LOGTMEIJER Christiaan
LUND Bert-Ove
LUDBORŽS Arnis
MULLOOLY Yvonne
LUSCHUTZKY Evita
PARIS Pietro
MAGGIORE Angelo
PASQUIER Elodie
MARQUEZ-CAMACHO Mercedes
PINA Benjamin
MOSSINK Jos
PRONK Marja
NYGREN Jonas
RUCKI Marian
ORISPÄÄ Katja
RUPPRICH Norbert
PELTOLA Jukka
SCHLÜTER Urs (3-5.12.)
RIVERO Debora
SCHULTE Agnes
RODRÍGUEZ IGLESIAS Pilar
SMITH Andrew
ROGGEMAN Maarten
SOERENSEN Peter
SADAM Diana
STASKO Jolanta
SOSNOWSKI Piotr
STOLZENBERG Hans-Christian
SPJUTH Linda
TADEO José Luis
STOYANOVA Evgenia
49
TSITSIMPIKOU Christina
THUVANDER Ann
Van der HAGEN Marianne
VAINIO Matti
VARNAI Veda Marija
VAN HAELST Anniek
VIVIER Stéphanie
Industry experts
Invited expert
BINKS Steve, Eurometaux, ILA (Lead
CLH and restriction)
BILLINGTON
Richard
ECPA,
DAS
(sulfoxaflor)
CROUDACE Charlotte, ECPA, Chemtura
(bifenazate)
FRAME
Steven,
ECPA,
DuPont
(triflusulfuron methyl, lenacil)
WARREN Simon, ECPA, Exponent
(AVKs)
LARSEN Poul Bo (4.12.)
SOGORB Miguel Angel
Dossier submitters
MÜLLER Severin, SI Group (TPP)
ROBERTS Linda Chevron (TPP)
Advisers to the RAC members
Remote participants
ESPOSITO Dania adviser to Pietro
Paris
HERINGA Minne adviser to Betty
Hakkert (remote)
MURRAY
Brendan
adviser
to
Thomasina Barron
PAPPONEN Hinni adviser to Riitta
Leinonen
PECZKOWSKA
Beata
adviser
to
Boguslaw Baranski, CLHadviser for
TPP
PRUTNER Wiebke adviser to Norbert
Rupprich, CLH adviser for bifenazate
ARMSTRONG
Keith,
IE
dossier
submitter (warfarin)
BEEKMAN
Martijn,
NL
dossier
submitter (NMP)
BRIGNON Jean-Marc, SEAC member
(AfA)
DANTINNE Catheline , SEAC member
(AfA9
EU Commission observers
BINTEIN Sylvain, DG ENV
LEFEBRE Remi, DG ENV
MORRIS Alick DG EMPL, SCOEL
ROZWADOWSKI Jacek, DG ENTR
SCAZZOLA Roberto, DG ENTR
Stakeholders observers
ANNYS Erwin, CEFIC
BARRY Frank, ETUC
MERCKEL Dan, OECD
MUNARI Tomaso, EuCheMS
ROMANO Dolores, EEB
ROWE Rocky, ECPA
FOCK Lars, SEAC member (NMP)
IVARSSON
Jenny,
SE
dossier
submitter (NP/NPE)
KIISKI Johanna, SEAC member (lead
restriction)
LESTANDER Dag, SE dossier submitter
(NP/NPE)
LUTTIKHUIZEN Cees, SEAC member
(AfA)
MULLER Andre, NL dossier submitter
(AVKs)
STARK
Christiane,
DE
dossier
submitter (fenpyroximate, tributyltin
compounds), adviser to Hans-Christian
Stolzenberg
TER
BURG
Wouter,
NL
dossier
submitter (NMP)
VASS
Anne
Marie,
SE
dossier
submitter (lead Restriction)
Excuses
LOSERT Annemarie, RAC member (
POLAKOVICOVA Helena RAC member
SPETSERIS Nikolaos, RAC member
TAYLOR Katy (ECEAE)
50
VEROUGSTRAETE Violaine,
Eurometaux
51
Part IV. LIST OF ANNEXES
ANNEX I
Final Agenda of the RAC-27 meeting
ANNEX II
List of documents submitted to the members of the Committee for
Risk Assessment for the RAC-27 meeting
ANNEX III
Declarations of conflicts of interest to the Agenda of the RAC-27
meeting
52
2 December 2013
RAC/A/27/2013
Final Agenda
th
27
meeting of the Committee for Risk Assessment
2-5 December 2013
ECHA Conference Centre, Annankatu 18, Helsinki
2 December: starts at 9:00
5 December: ends at 14:00
Item 1 – Welcome and Apologies
Item 2 – Adoption of the Agenda
RAC/A/27/2013
For adoption
Item 3 – Declarations of conflicts of interest to the Agenda
Item 4 – Report from other ECHA bodies and activities
a) Report on RAC 26 action points, written procedures and other ECHA
bodies
RAC/27/2013/01
For information
b) RAC workplan for all processes
For information
Item 5 – Harmonised classification and labelling (CLH)
5.1 CLH dossiers
a) Sulfoxaflor
b) Phenol, dodecyl-, branched (TPP)
c) Lead
d) Anti-coagulant rodenticides
a. Flocoumafen
b. Warfarin
53
c. Brodifacoum
e) Triflusulfuron methyl
f)
Bifenazate
g) Fenpyroximate
h) Lenacil
i)
Tributyltin compounds
For discussion/adoption
5.2 Appointment of RAC (co-) Rapporteurs for CLH dossiers
RAC/27/2013/02 (confidential room document)
For agreement
5.3 General and procedural CLH issues
a) State of play of CLH dossiers
RAC/27/2013/03
For information
Item 6 – Restrictions
6.1
General restriction issues
a) Update on intended restriction dossiers
For information
b) Revision of the restriction process
RAC/27/2013/04
For discussion/agreement
RAC/27/2013/09
For information
6.2
Restriction Annex XV dossiers
a) Lead in consumer articles – 4th version of the draft opinion
For adoption
st
b) Nonyl phenol – 1 version of the draft opinion
For discussion
c) 1-Methyl-2-pyrrolidone (NMP) – 1st version of the draft opinion
For discussion
d) Cadmium in paints- outcome of conformity check
For agreement
54
6.3
Appointment of (co-) Rapporteurs for restriction dossiers
RAC/27/2013/05 (confidential room document)
For information/agreement
Item 7 – Authorisation
7.1
Authorisation applications
c) Authorisation application on the use of DEHP in a stop-off
formulation in manufacturing of aero engines – first version of the
draft opinion
For discussion/agreement
d) Authorisation applications on Phthalates (submitted within the
August submission window) - outcome of the conformity check
For agreement
7.2
Capacity building
c) ECHA project on carcinogenicity dose-response analysis of Cr (VI)and As-containing substances
RAC/27/2013/06
RAC/27/2013/07
For discussion/agreement
d) ECHA project on carcinogenicity dose response analysis of
Trichloroethylene
For information
7.3
Appointment of (co-) Rapporteurs for authorisation applications
RAC/27/2013/08 (confidential room document)
For agreement
Item 8 – AOB

Update on Guidance activities
Item 9 – Action points and main conclusions of RAC-27

Table with Conclusions and Action points from RAC-27
For adoption
55
ANNEX II (RAC-27)
Documents submitted to the members of the Committee for Risk
Assessment for the RAC-27 meeting.
Document number
Title
RAC/A/27/2013
Final Draft Agenda
RAC/27/2013/01
Report from other ECHA bodies and activities
RAC/27/2013/02
Appointment of RAC (co-) Rapporteurs for CLH dossiers
Room document
RAC/27/2013/03
Status Report on Harmonised
Labelling proposals (CLH Dossiers)
RAC/27/2013/04
Revision of the working procedure for RAC and SEAC
on conformity check of Annex XV restriction dossiers
RAC/27/2013/05
Appointment
dossiers
Room document
of
(co-)
Classification
Rapporteurs
for
and
restriction
RAC/27/2013/06
ECHA project on carcinogenicity dose-response
analysis of Cr (VI)-containing substances
RAC/27/2013/07
ECHA project on carcinogenicity
analysis of As -containing substances
RAC/27/2013/08
Appointment of (co-) Rapporteurs for authorisation
applications
Room document
RAC/27/2013/09
dose-response
Questionnaire and setting task force in relation to
efficiencies in Annex XV dossier preparation for
restrictions proposals and subsequent opinion making
56
ANNEX III (RAC-27)
The following participants, including those for whom the Chairman
declared the interest on their behalf, declared potential conflicts of
interest with the agenda items (according to Art 9 (2) of RAC RoPs)
AP/Dossier / DS
Reason for potential CoI /
Working for
RAC member
ALREADY DECLARED AT RAC 26
CLH: Sulfoxaflor (IE)
Thomasina BARRON
CLH: Lead (SE)
Bert-Ove LUND
CLH: Flocoumafen
(NL)
Betty HAKKERT3
Marja PRONK1
CLH: Warfarin (IE)
Thomasina BARRON
CLH: Brodifacoum
(IT)
Paola di PROSPERO
CLH: Coumatetralyl
(DK)
Peter SOERENSEN
Frank JENSEN
CLH: Bromadiolone
(SE)
3
Bert-Ove LUND
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
Potential CoI declared by the Chairman, member disagreed
57
AP/Dossier / DS
RAC member
CLH: Difenacoum
(FI)
Riitta LEINONEN
CLH: Difethialone
(NO)
Marianne van der
HAGEN
Christine BJØRGE
RESTR. Lead in
consumer articles
(SE)
Bert-Ove LUND
RESTR. Nonylphenol
(SE)
Bert-Ove LUND
Reason for potential CoI /
Working for
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
dossier; asked to refrain from voting
in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
dossier; asked to refrain from voting
in the event of a vote on this
substance - no other mitigation
measures applied.
58
New dossiers
AP/Dossier / DS
RAC member
Reason for potential CoI /
Working for
NEW
CLH: Triflusulfuron
methyl (FR)
Elodie PASQUIER
CLH: Bifenazate (NL)
Betty HAKKERT1
Marja PRONK1
CLH: Fenpyroximate
(DE)
Urs SCHUELTER
Norbert RUPPRICH
Agnes SCHULTE
CLH: Lenacil (BE)
CLH: Tributyltin
compounds
(DE)
Hans-Christian
STOLZENBERG
Safia KORATI
Urs SCHUELTER
Norbert RUPPRICH
Agnes SCHULTE
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Collaborated with the CA submitting
the CLH dossier
His employer collaborated with the CA
submitting the CLH dossier
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
CLH dossier; asked to refrain from
voting in the event of a vote on this
substance - no other mitigation
measures applied.
Collaborated with the CA submitting
the CLH dossier
59
AP/Dossier / DS
RESTR: 1-Methyl-2pyrrolidone (NMP;
NL)
RAC member
Betty HAKKERT4
Marja PRONK
4
Reason for potential CoI /
Working for
Working for the CA submitting the
dossier; asked to refrain from voting
in the event of a vote on this
substance - no other mitigation
measures applied.
Working for the CA submitting the
dossier; asked to refrain from voting
in the event of a vote on this
substance - no other mitigation
measures applied.
RAC members’ advisers
AP/Dossier / DS
RAC member
adviser
CLH: Sulfoxaflor (IE)
Brendan MURRAY
CLH: Warfarin (IE)
Brendan MURRAY
CLH:
Chlorophacinone
(ES)
Miguel SOGORB
Reason for potential CoI /
Working for
Working for the CA submitting the
CLH dossier
Working for the CA submitting the
CLH dossier
Collaborated with the CA for the
assessment of the biocide dossier for
this rodenticide
o0o
4
Potential CoI declared by the Chairman, member disagreed
60